Pharmaceutical Quality Management of Dexamethasone tablets BP
Dexamethasone tablets USP
DEXAMETHSONE OPTHALMIC SUSPENSION BP
DEXAMETHSONE OPTHALMIC SUSPENSION USP
Dexamethasone is a synthetic (man-made) corticosteroid.
Corticosteroids are naturally-occurring chemicals produced by the adrenal glands located above the kidneys.
Dexamethasone Sodium Phosphate Injections (Dexona Injections) is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, Cerebral oedema(raised intracranial pressure),auto-immune, endocrine, pulmonary, blood disorders or breathing disorders.
Pharmacological Classification, Mechanism of Action, Clinical Uses, Administration Routes, Dosing for Adults and Pediatrics, Pharmacokinetics, Dose Adjustments, Patient Counseling, Adverse Effects, Drug Interactions, Contraindications, Personal Experience with Ondansetron, Future Clinical Uses of Ondansetron
Dexamethasone Sodium Phosphate Injections (Dexona Injections) is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, Cerebral oedema(raised intracranial pressure),auto-immune, endocrine, pulmonary, blood disorders or breathing disorders.
Pharmacological Classification, Mechanism of Action, Clinical Uses, Administration Routes, Dosing for Adults and Pediatrics, Pharmacokinetics, Dose Adjustments, Patient Counseling, Adverse Effects, Drug Interactions, Contraindications, Personal Experience with Ondansetron, Future Clinical Uses of Ondansetron
Ondansetron
Class
• Seratonin ( 5-HT3) antagonist.
Uses
1. The management of nausea and vomiting induced by chemotherapy and
radiotherapy .
2. In the prevention and treatment of PONV
Main action
• Antiemetic.
Digoxin & Nitroglycerin by Dr. Sanaullah Aslam (Complete)Sanaullah Aslam
Your Feedback will be highly appreciated. This presentation was made for students at pharmacy institute in a project of clinical pharmacy and use of digoxin and nitroglycerin. This presentation is made so that you can present it in a same session, without any change.
In this presentation, mainly I concentrated on Metronidazole, which is an anti-biotic; and talking about it's pharmacokinetics, drug indication, contraindication, adverse drug reactions and taking the drug during pregnancy and lactation, finally I hope you enjoy it as much as I DID, SALAAM.
Ondansetron
Class
• Seratonin ( 5-HT3) antagonist.
Uses
1. The management of nausea and vomiting induced by chemotherapy and
radiotherapy .
2. In the prevention and treatment of PONV
Main action
• Antiemetic.
Digoxin & Nitroglycerin by Dr. Sanaullah Aslam (Complete)Sanaullah Aslam
Your Feedback will be highly appreciated. This presentation was made for students at pharmacy institute in a project of clinical pharmacy and use of digoxin and nitroglycerin. This presentation is made so that you can present it in a same session, without any change.
In this presentation, mainly I concentrated on Metronidazole, which is an anti-biotic; and talking about it's pharmacokinetics, drug indication, contraindication, adverse drug reactions and taking the drug during pregnancy and lactation, finally I hope you enjoy it as much as I DID, SALAAM.
Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean S...احمد عبدالراضى
Dexamethasone in Prevention of Respiratory Morbidity in
Elective Caesarean Section in Term Fetus
Qena University Hospital Experience
By
Ahmed Abdel-Rady Ali
(M.B, B.Ch.)
Resident physician in obstetrics and gynecology
Qena University Hospital
South Valley University
Analytical Method Development and Validation of Dutasteride and Tamsulosin Hc...SriramNagarajan15
A simple,specific, sensitive,precise and reproducible Reverse Phase High Performance liquid Chromatography method has been developed for simultaneous estimation of Dutasteride and Tamsulosin Hcl. Dutasteride and Tamsulosin is Anti-hyperplasia and Anti-hypertensive drug.The determinationwas carried out byusingsymmetryC-18columnwith Methanol:0.1M Monobasic potassiumdihydrogenphosphate buffer(75:25) Adjusted the pH to 2.5 with Ortho phosporic acid as the mobile phase and with the detection wavelength of274 nmrespectively.The flow rate is 0.7 ml/min.TheRetentiontime of Dutasteride,Tamsulosin Hcl was 2.218 minand 6.599 min respectively.Linearityforthe Dutasteride and Tamsulosin Hcl were found inthe rangeof 25-75µgmand 20-60µgm respectively.The limitof quantificationforbothdrugs wasfound to be30,24µg respectively.The recoveries of Tamsulosin and Dutasteride were found to be inthe range of 99.81-99.90 %and98.00-102.00%, respectively. The proposed method was validated suitably and canbeused for routine analysis. The degradation studies indicated Dutasteride and Tamsulosin Hcl to besusceptible to neutralhydrolysis, while Dutasteride and Tamsulosin Hcl showed degradation inacid, H2O2,photolytic and inpresenceof UV radiation.The degradation productsof Dutasteride andTamsulosin Hcl inacidic and photolytic conditions were well resolved from the pure drug with significant differences in the irretention time values. This method can be successfully employed forsimultaneous quantitative analysis of Dutasteride and Tamsulosin Hcl in formulations.
Stability indicating method development and validation for the estimation of ...SriramNagarajan18
Stability indicating method development and validation for the estimation of Doxorubicin by using RP-HPLC method in a bulk and pharmaceutical dosage form
Advertising media refers to the various channels or vehicles through which promotional content is communicated in various forms such as text, speech, images, videos etc.
antidotes and their MOA
An antidote is a substance which can counteract a form of poisoning. The term ultimately derives from the Greek αντιδιδοναι antididonai, "given against"
Natural compounds from the bark of the cinchona tree, most notably quinine was observed to exhibit antimalarial activity.
Until the development of synthetic derivatives (ie. 4-aminoquinoline antimalarials), quinine continued to be the first choice to treat malaria.
Quinine is associated with side effects such as diarrhœa.
4-aminoquinoline antimalarials such as amodiaquine and chloroquine largely replaced quinine because of reduced unpleasant side effects.
The life cycle of the parasite and the immunological defence mechanisms against the parasite are complex.
Part of the parasite’s life cycle involves invasion of red blood cells (erythrocytes).
The haemoglobin within the red blood cell is broken down by the parasite and is used as a source of amino acids.
The 4-aminoquinolines act at the erythrocytic stage of the parasite.
Doxycycline is a compound used in prophylaxis against plasmodial parasites.
Other compounds associated with treating malaria include halofantrine and lumefantrine, often used in combination with other drugs.
Epilepsy
Epilepsy is a group is neurological disorder. An epileptic seizure is a paroxysm(sudden) of uncontrolled discharges of neurons causing an event that is discernible(visible) by the person experiencing the seizures or by the observer. The tendency to have recurrent attacks is known as epilepsy.
phenytoin,phenobarbital,sodium valporate ,carbamazepine,clonazepam and diazepam, lamotrigine,pregabalin,felbamate,zonisamide, ETHOSUXIMIDE, LEVETIRACETAM, OXACARBAZEPINE, PRIMIDONE
RESEARCH IN HOSPITAL PHARMACY and PHARMACY EDUCATIONAsra Hameed
RESEARCH IN HOSPITAL PHARMACY:
Advancement of pharmacy practice and healthcare
Pharmacists play a vital role in the health care system through the medicine and information they provide. Pharmacy education is the broad term which mainly involves the
Pharmacist educational requirements and carrier
Patient education
1) BASED ON THE CHEMICAL NATURE OF NON SUGAR MOIETY
2) BASED ON TE NATURE OF SUGAR MOITY
3) BASED ON LINKAGE BETWEEN GLYCON AND AGLYCON PORTION
4) BASED ON THERAPEUTIC NATURE OF GLYCOSIDE
ALLAH Kareem nay Hazrat Muhammad S.A.W.W ko tmaam insaaniyat kay lye rehmat bna kr bheja, jnki sadaqat ki gawahi kaafir be daitay thay, tau aisay Nabi aur Khuda ka mazhab deshatgardi aur khoonraizi ki ijazat kaisay dy skta hai?
Introduction:
Poverty Condition in Pakistan
Causes/Reasons of poverty in Pakistan
Effects of poverty in Pakistan
Solutions/Remedies to Overcome the Poverty in Pakistan
Conclusion
Dengue (pronounced DENG-gay) can affect anyone but tends to be more severe in people with compromised immune systems. Because it is caused by one of four serotypes of virus, it is possible to get dengue fever multiple times. However, an attack of dengue produces immunity for a lifetime to that particular serotype to which the patient was exposed.
Essential oils are volatile (quickly evaporating) aromatic fluids extracted from plants through steam distillation, or in the case of citrus fruits through expression (or cold pressing) of the rind to obtain an oil that retains a juicy, fresh fruit scent.
Various extraction methods are used in the manufacture and extraction of essential oils, and the method used is normally dependant on what type of botanical material is being used.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
4.
Dexamethasone
is a synthetic
(man-made)
corticosteroid.
Corticosteroids
are naturally-
occurring
chemicals
produced by the
adrenal glands
located above
the kidneys.
Corticosteroids
affect the
function of
many cells
within the body
and suppress
the immune
system.
Corticosteroids
also block
inflammation
and are used in
a wide variety
of inflammatory
diseases
affecting many
organs.
The FDA
approved
dexamethasone
in October
1958.
DEXAMETHASONE
5.
Dexamethasone Tablets Contain Dexamethasone.
CONTENT OF DEXAMETHASONE:
95.0 to 105.0% of the stated amount.
ACTION AND USE:
Glucocorticoid.
DEXAMETHASONE TABLETS
6.
Powdered
Tablets
containing 20
mg of
dexamethasone
+ 5ml of 0.1M
NaOH.
Add 50ml
dichlorometh
ane mix with
aid of
ultrasound
(20min)
Filter layer of
dichlorometh
ane ,
evaporate it
with using a
rotary
evaporator
Dry residue
at 105℃ for 2
hours.
Check the
absorption at
infrared
spectrum of
the dried
residue.
IDENTIFICATION
7.
Tablets containing less than 2mg or less
than 2% w/w of dexamethasone
comply with the requirement
Carry out the method for liquid
chromatography
UNIFORMITY OF CONTENT
Tablet +sufficient methanol (50%)
solution of 0.0025% w/v of
dexamethasone
shake (10min)
filter
8.
(2)
CHROMATOGRAPHICCONDITIONS:
Stainless steel column
Isocratic elution
Flow rate of 1.4ml/min
Ambient column temperature
Detection wavelength of 238nm
Inject 20µL of each solution
0.0025% w/v of dexamethasone
in methanol (50%)
10.
Tablets containing less than 2mg or less than 2% w/w
of dexamethasone
ASSAY
Use the average of the 10 individual results
obtained in the test for uniformity of content
11.
Tablets containing 2mg or more than 2% w/w of
Dexamethasone:
(1)
ASSAY
Powdered tablets + 2.5 mg
dexamethasone + 20ml methanol
shake (20min)
filter
14.
Dexamethasone tablet contains not
less than 90.0 %and not more than
110.0% of the label amount of
dexamethasone.
Packaging And Storage: preserve
in well close container.
Introduction
15.
Process by
which solvent
enter solid
substance to
yield a solution.
Dissolution
medium:
solvent or
medium in
which
substance is
dissolve.
Medium: dilute
hydrochloric
acid (1
in100ml).
Apparatus
1:100 RPM.
Time:45min.
Standard
solution:
prepare as
directed for std.
preparation and
assay of
steroids, using
dexamethasone
RS.
Dissolution
16.
Extract a filtered aliquot (dissolution medium) about200 micro
gm. of dexamethasone with 3 portions of
chloroform(15ml).Evaporate this extract to dryness on steam
bath, cool it and dissolve the residue(extract) in 20ml of alcohol.
Calculate the portion in mg of dexamethasone dissolve.
Tolerance: not less than 70% label amount of dexamethasone is
dissolve in 45 minutes.
Procedure
17.
DIFFERENCE B/W CONTENT
UNIFORMITY & ASSAY
Uniformity of content is by two
methods by weight variation and by
content uniformity.
Weight variation means performing
assay and relating with individual unit
of dosage form.
Content uniformity means for ten
sample (dosage unit) individually
analysed.
18.
PROCEDURE FOR
CONTENT UNIFORMITY
STANDARD SOLUTION:
Prepare as directed for Standard Preparation under Assay for steroids using USP
Dexamethasone RS.
TEST SOLUTION:
Place 1 tablet in a separator with 15ml of water and swirl to disintegrate
completely.
Extract with four 10ml portion through chloroform-washed cotton into 50ml
volumetric flask.
Add chloroform to volume and mix.
Pipette a volume of this solution equivalent to 200microgram of dexomethasone
into a glass stoppered 50ml conical flask.
19. Proceed as
directed for
Procedure under
Assay for
steroids, except to
allow to stand in
the dark for 45
mins.
Calculate the
quantity in mg of
total steroids as
C22H29FO5 in
the tablet by the
formula:
(C/V)(AU / AS)
In which V is the
volume in ml of
the aliquot taken
to prepare the
Test solution.
20.
ASSAY
MOBILE SOLVENT:
Prepare a suitable aqueous solution of acetonitrile
approximately 1 in 3 , such that the retention time of
dexomethasone is b/w 3 mins and 6 mins.
STANDARD PREPARATION:
Dissolve an accurately weighd quantity of USP
Dexamethasone RS in dilute methanol to obtain a solution
having a known concentration of about 0.1 mg per ml.
21. ASSAY PREPARATION:
Weigh and finely powder not fewer than 10 tablets.
Weigh accurately a portion of powder equivalent to about 5 mg
of dexamethasone.
Transfer to a 50ml volumetric flask and add 30 ml of dilute
methanol.
Sonicate the flask for about 2 mins , shake by mechanical means for 30 mins.
Dilute with the same solvent to volume.
Filter a portion of mixture through a suitable filter to obtain a clear filtrate.
22. PROCEDURE
Introduce equal volumes of the Assay preparation and the Standard
preparation into a high pressure liquid chromatograph operated at room
temperature by means of a loop injector, adjusting the specimen size other
operating parameters such that the peak obtained with the Standard
preparation is about 0.6 full scale.
The apparatus is fitted with a 4.6 mm × 30 cm column packed with packing L1
and is equipped with an UV detector capable of monitoring absorption at 254
nm and a suitable recorder.
In a suitable chromatogram , the coefficient of variation for five replicate
injections of a single specimen is not more than 3 %.
23. Measure the
responses of the
peaks at
identical
retention times
obtained with
the Assay
preparation and
the Standard
preparation.
Calculate the
quantity in mg
of C22H29FO5
in the portion of
tablets taken
by the formula:
50C(ru/rs)
In which C= is
the
concentration
in mg per ml of
USP
Dexamethasone
RS in the
Standard
preparation .
ru and rs = are
the peak
responses
obtained from
the Assay
preparation
and the
Standard
preparation.
25.
Dexamethasone suspension: a sterile suspension of
dexamethasone in a suitable vehicle.
CONTENT OF DEXAMETHASONE:
95.0 to 105.0% of the stated amount.
ACTION AND USE:
Glucocorticoid.
Introduction:
26.
Eye drop
containing 20 mg
of dexamethasone
+ 5ml of 0.1M
NaOH.
Add 50ml
dichloromethane
mix with aid of
ultrasound
(20min)
Filter layer of
dichloromethane ,
evaporate it with
using a rotary
evaporator
Dry residue at
105℃ for 2 hours.
Check the
absorption at
infrared spectrum
of the dried
residue.
IDENTIFICATION
27.
PARTICLE SIZE
Examine using an automated light obscuration instrument
Not more than 20 particle >25µm
Not more than 2 particle >50µm
No particles >90µm.
ACIDITY
pH,5.0 to 6.0
TESTS:
28.
•Carry out the method for Liquid chromatography
•Dispense a quantity of eye drop containing 20mg of dexamethasone in 70ml of
mobile phase, mix the aid of ultrasound for 10 min, dilute with sufficient water to
produce 100 ml and filter.
•0.02% w/v of dexamethasone BPCRS
•0.01% w/v of dexamethasone impurity standard BPCRS.
ASSAY
29.
Related susbstance may be used :
SYSTEM STABILITY:
Test in not valid unless chromatogram obtained with solution (3).
Resolution factor between the peaks id due to impurity 3 and
dexamethasone is atleast 1.5
the chromatogram supplied with dexamethasone impurity standard
BPGRS.
CHROMATOGRAPHIC
CONDITIONS:
30. •Calculate the content of
C22H29FO5 in the eyedrop
using the declared content of
C22H29FO5 in
dexamethasone BPGRS.
DETERMINATION
OF CONTENT
•Should be stored in
accordance with
manufacturer’s instructions.
STORAGE
34.
Dexamethasone ophthalmic suspension of
dexamethasone containing a suitable
antimicrobial preservative
It may contain suitable buffers, stabilizers and
suspending and viscosity agent
It contains not less than 90.0 percent and not
more than 110.0 percent of the labeled amount
of 22H29FO5
INTRODUCTION
36.
Transfer a volume of ophthalmic suspension equivalent to about
2.5 mg of dexamethasone to a test tube ,add ml of chloroform and
shake.
Centrifuge and apply 10µL of the chloroform layer and 10µL of a
standard solution of usp .Dexamethasone RS in chloroform
containing 500µg per ml on a thin layer chromatographic plate
coated with a 0.25mm layer of chromatographic silica gel mixture
Develop the chromatogram in solvent A as directed under single
steroid assay
IDENTIFICATION:
37.
Mark the solvent front
and locate the spots on
the plate by spraying
with a 1 in 5 solution of
p-toluene sulfonic acid
in a mixture of 9
volume of alcohol and
volume of propylene
glycol and heating until
spots appear
The Rf value of
the principal spot
obtained from
the solution
under test
corresponds to
that obtained
from the
standard solution
38.
STERILITY
Should be meet the requirement
Media Membrane
Filtration
Aqueous
Solutions
Direct
Inoculation of
the Culture
Media
Observation And
Interpretation Of
Results
Rabbit
Pyrogen Test
Pyrogen Test Spark Test Leaker Test
41. ASSAY
ASSAY PREPARATION
measured volume of Opthalmic
Suspension (3mg of
dexamethasone)
25 mL volumetric flask
dilute with mobile phase to
volume & mix
CHROMATOGRAPHIC SYSTEM
254-nm detector
4.6-mm*25-cm column (packing L1)
Flow rate is about 2 mL/min
Chromatograph standard
preparation & record peak response
column efficiency is not
< 1750 , tailing factor is not
> 3.0 & the relative SD for replicate
injection is not > 3.0%
42. Separately inject equal volumes of the standard preparation
and the assay preparation into the chromatograph, record
the chromatographs and measure the responses for the
major peaks.Calculate the quantity in mg of Dexamethasone
in each mL of the opthalmic suspension using formula:
25(C/V)(ru/rs)
43.
44.
TEST RANGE/ LIMIT RESULT
COMMENTS/
REMARKS
Identification
IR spectrum
Concordant with
RS 089
Concordant. Identified.
Uniformity of
content
L1 (maximum
allowed
acceptance
value) is 15
A.V= 5.6 Accepted.
Assay 95-105% 97% Accepted.
Dexamethasone tablets
BP
45.
TEST RANGE/ LIMIT RESULT
COMMENTS/
REMARKS
Identification
RF value corresponds
to standard.
Corresponded. Identified.
Dissolution
Not less than 70% of
labeled amount of
C22H29FO5 is
dissolved in
45minutes.
85% C22H29FO5
is dissolved.
Passed.
Uniformity of
dosage units
L1 (maximum
allowed acceptance
value) is 15
A.V = 5.6 Accepted.
Assay 90-110 % 97% Accepted.
Dexamethasone tablets
USP
46.
DEXAMETHSONE OPTHALMIC
SUSPENSION BP
TEST RANGE/ LIMIT RESULT
COMMENTS/
REMARKS
Identification
IR spectrum Concordant
with RS 089
Concordant. Identified.
Particle size
Not more than 20 particles
>25µm
Not more than 2particles
>50µm
No particle >90µm
19paricles are
>25µm
1 particle is
>50µm
No particle is
>90µm
Accepted.
Acidity pH 5.0-6.0 pH is 5.6 Accepted.
Assay 95-105% 97% Accepted.
47.
DEXAMETHSONE OPTHALMIC
SUSPENSION USP
TEST RANGE/ LIMIT RESULT
COMMENTS/
REMARKS
Identification
RF value corresponds
to standard.
Corresponded. Identified.
Sterility
Should be no
evidence of microbial
growth.
The product
complies with
the test for
sterility.
Passed the
sterility test.
pH 5.0-6.0 pH is 5.6 Accepted.
Assay 90-110 % 97% Accepted.