The best technology inventions ever

1. T Furuta et al., J Pai n Relief 2016, 5:3(Suppl)
http://dx.doi.org/10.4172/2167-0846.C1.006
International Conference on
Fibromyalgia and Chronic Pain (June 15-16, 2016 Philadelphia,
USA)
1
HPLC technology for estimation of single max impurity, common halogen
impurity, unspecified impurity associated with detectable impurity, invention
discloses for new pharmacopeial standards-setting of a drug product
Rahul Hajare, Post Doc. PhD, Rajgad Dnyanpeeth’s
College of Pharmacy, INDIA
As a Former Post-Doctoral Fellow, Department of Health
Research Indian Council of Medical Research, New Delhi
Abstract
Purity or limits of impurity and its coping
measurements for drug products present a challenge
to pharmacopeial standards-setting of a drug
product over time is at issue, the same analytical
methods that are stability-indicating are also purity-
indicating. Resolution of the active ingredient(s) from
preparation presents the same qualitative problem.
Thus, many monographs for Pharmacopeial
preparations feature chromatographic assays.
Where more significant impurities are known, some
new monographs set forth specific limit tests. In
general, however, this pharmacopeia does not
repeat impurity tests in subsequent preparations
where those appear in the monographs of drug
substances and where those impurities are not
expected to increase. Here close monitoring of
unique recombination formation of impurity amplified
and sequenced. The implementation of the new
monograph requirement concerning single max
impurity, common halogen impurity and unspecified
impurity associated detectable impurity in synthetic
drug substances aim at better quality
characterization of those human products and thus at
better medicinal product in the market. The invention
discloses drug development and methods and it has
updated regularly. Single max impurity: Not more
than 1.5 times the area of the principal peaks in the
chromatogram obtained with reference solution (c)
(0.3 per cent). Common halogen impurity: Not more
than the area of the principal peaks in the
chromatogram obtained with references solution (c)
(0.2 per cent). Unspecified impurity associated with
detectable impurity: Not more than the area of the
principal peaks in the chromatogram obtained with
references solution (c) (0.10 per cent).Total impurity
not more than 0.6 per cent the area of the principal
peaks in the chromatogram obtained with reference
solution(c). Reference solution (a). Dissolve 25.0 mg of
reference compound in the mobile phase and dilute
to 50.0 ml with the mobile phase. Reference solution
(c): Dilute 1.0 ml of the test solution to 50.0 ml with
the mobile phase. Dilute 1.0 ml this solution to 10.0
ml with the mobile phase.
Mobile phase: Mix 13 volumes of acetonitrile and 83
volumes of a 2.45gm/L solution of phosphoric acid
previously adjusted to pH 3.0 with triethylamine. Flow
rate: 1.5 ml/min Detection: Spectrophotometer at 278
nm Injection: 50 ul of the test solution and refence
solution (c) Test solution: Dissolve 25.0 mg of the
substance to be examined in the mobile phase and
dilute to 50.0 ml with the mobile phase. Correction
factor: for the calculation of content multyply the
peaks areas of the following impurities by the
corresponding correction factors: Single max impurity:
6.7. Common halogen impurity: 0.7.Unspecified
impurity associated with detectable impurity: 0.6
Assay Liquid chromatography (2.2.29 European
Pharmacopeia 5.0) as described in the test for related
substances with the following modifications. Injection:
10 μl; inject the test solution and reference solution (a).
Impurities with product in above section monograph
components are under general notices and
requirements as well as general ordinary impurities.
Addressed topic of purity or impurity has come up into
focus when handling validation of compendial
procedure of laboratory product 1H- Indole 2,3,
Dione (Isatin).
Recent Publications
1. pre_DR Technology. ( 2016 ) KJACT-100106 Volume 2, Issue 1 -3
2. E-IPA-Encyclopedia of Impurity Profile (IP) for API, (2017),The Pharma
Innovation Journal ; 6(1): 05-06
3. Matrix Impurity, Disregards Impurity, Specified Impurity Associated
Undetectable Impurity: Monograph (2017), World J Pharm Pharm
Sci. Volume 6, Issue 1, 242-246
4. Classical Technology Can Run Away Impurity in Pharmaceuticals Frugal
Innovation Lesson from Classic Innovation System. Opinion article (2017),
Organic & Medicinal Chem IJ. Volume 2 Issue 4: DOI:
10.19080/OMCIJ.2017.02.555592.
5. Tertiary Care in Impurity Trends New Pattern Discovery: Letter to Editor.
(2017), Organic & Medicinal Chem IJ. Volume 2 Issue 4
DOI:10.19080/OMCIJ.2017.02.555592.
6. UPLC technology re-discover the techniques for
characterization of impurities and impurities
emission., 9 th Annual Congress on Drug Design &
Drug Formulation 2017, Seoul, South Korea

2. T Furuta et al., J Pai n Relief 2016, 5:3(Suppl)
http://dx.doi.org/10.4172/2167-0846.C1.006
International Conference on
Fibromyalgia and Chronic Pain (June 15-16, 2016 Philadelphia,
USA)
2
Biography:
Dr. Rahul A. Hajare has expertise in HIV Drug
Technology, Computer Chemistry, Binding Energy,
Thermodynamics, Physical Chemistry, Biological
Development, Vaccine, Model speeds drug discovery,
Molecular modeling Drug Design, Synthesis and QSAR,
Impurity trends. Dr. Hajare is a post-doctoral fellow
2013 (7 th Batch) funded by the Indian Council of
Medical Research, New Delhi, under the guidance of
Hon’ble Dr. Ramesh Paranjape, Former Director &
Scientist ‘G’ National AIDS Research Institute Pune He
is a member of ACS, AAPS, Biomaterial Society,
OMICS International and CVC Government of India.
Email:drrahulhajare@rediffmail.com