With the advancement of science and changes in the way people think, healthcare products are increasingly related to everyone's life. In the field of healthcare, safety is paramount, and cooperation with a professional and reliable analytical and testing company that has a world-class reputation for delivering quality and value is vital to your success. Whether you are a consumer or a supplier, Alfa Chemistry is a trusted partner with rich knowledge and experience in providing healthcare testing services

1. Testing Services
Comprehensive Testing Services to Support Product
Development and Production Quality Control
www.alfachemic.com/testinglab/industries/healt
hcare.html
HEALTHCARE
PRODUCTS

2. As a comprehensive healthcare
products testing partner, you'll enjoy
the benefit of a single source
supplier for your testing needs, from
feasibility and R&D to product
development and production quality
control.
HEALTHCARE
PRODUCTS
SERVICES
01

3. Our staff of specialists can handle
your products under ISO, USP, CEN,
IEC, WHO and Best Industry Practices.
REGULATIONS
02

4. Alfa Chemistry is a comprehensive
analysis testing company that
provides one-stop testing, analysis
and technical support services in the
areas of Food, Agriculture Products
& Crop, Personal Care & Beauty
Products, Healthcare Products, Fine
Chemicals Products, Energy,
Environment, Material, Household &
Apparel Products, Stationery & Office
Supplies, and Children’s Products.
ALFA CHEMISTRY
TESTING LAB
03

5. Outline
Alfa Chemistry will be your single source supplier for all of your
testing needs.
Dietary Supplements Medicine Medical Device

6. Dietary Supplements Testing
Dietary supplements are defined in the US Drug Supplement Health and
Education Act of 1994 as a product (other than tobacco) that includes one or
more of the dietary ingredients like vitamin, mineral, herb or other botanical,
amino acid, or any other substance used to supplement the diet by increasing
total dietary intake, metabolite, constituent, extract, or combination of any of the
above. The FDA has established good manufacturing practices (GMPs) for
dietary supplements to help ensure their identity, purity, strength, and composition.
These GMPs are designed to prevent the inclusion of the wrong ingredient, the
addition of too much or too little of an ingredient, the possibility of contamination,
and the improper packaging and labeling of a product. As a reliable third-party
testing company, Alfa Chemistry provides dietary supplements testing services to
clients around the world according to industry standards to ensure the quality and
safety of your products.
Industry Regulations
 U.S. Food & Drug Administration  International Organization for
Standardization
 ...... Dietary Supplements Health and
Education Act
Products Service Test items Platforms
Tea
Wine
Bee products
Drinks
Soups
Fresh juice
Medicated diet
Gelatin
Calcium tablet
High calcium
tablet
etc.
Effective
ingredients
Flavonoids
Anthocyanins, tea polyphenols, soy isoflavones,
rutin, baicalin, puerarin, catechin, ginkgol,
psoralen, dried tallow, icariin, etc.
HPLC
FTIR
GC
ICP-MS
IC
Shimadzu
SFC/UHPLC
ICP-AES
LC-MS
Saponins
Ginsenosides, glycyrrhizin, polygala saponins,
panax notoginseng saponins, etc.
Phenylpropanoid
Caffeic acid, eugenol, cinnamaldehyde, anisole,
chlorogenic acid, asarone, etc.
Terpenes and
volatile oils
Citral, menthone, eucalyptol, cantharidin,
camphor, borneol, artemisinin, sterol
glycosides, etc.
Other categories Cordycepic acid, cordycepin, SOD enzyme, etc.
Microorganis
m
Total number of colonies, staphylococcus aureus, escherichia coli,
lactobacillus, botox, salmonella, streptococcus, etc.
Harmful
substance
Nitrite, melamine, benzopyrene, aflatoxin, sulfur dioxide, etc.
Heavy metal Lead, mercury, chromium, cadmium, arsenic, etc.
Hormone
content
Sex hormone
Estriol, estradiol, estrone, diethylstilbestrol,
testosterone, methyltestosterone, progesterone,
seven sex hormones, etc.
Glucocorticoid
Qu anxilong, prednisolone, hydrocortisone,
prednisone, cortisone, methylprednisolone,
betamethasone, etc.

7. Medicine Testing
To assure drug quality, various countries have published texts commonly
called compendia or pharmacopoeias, such as United States Pharmacopoeia
(USP), the European Pharmacopoeia, and the Japanese Pharmacopoeia,
that list official test methods as well as specifications for commonly used drug
products. The QC analytical laboratory is the final step in a long line of
processes where many individuals from diverse departments take part to
ensure the safety, efficacy, and quality of drug products. Analytical testing is
one of the more interesting ways for scientists to take part in the quality
process by providing actual data on the identity, content, and purity of drug
products. As a reliable third-party testing company, Alfa Chemistry provides
medicine testing services to clients around the world according to industry
standards to ensure the quality and safety of your products.
Industry Regulations
 European Pharmacopoeia U.S. Food & Drug Administration
 ...... United States Pharmacopoeia
Product Service Test items Platforms
Chemical
medicine
Limit detection Spectroscopy, chromatography,
mass spectrometry, others
HPLC
GC
ICP-MS
IC
ISQ™ QD GC-MS
Shimadzu SFC/UHPLC
ICP-AES
LC-MS
Capillary Electrophoresis
Apparatus
Content analysis
Chloride, iron salt, heavy metal,
loss on drying, ash, sulfate,
selenium, fluorine, ammonium salt,
easy carbide, residual solvent,
thermal analysis, total organic
carbon in pharmaceutical water,
conductivity of pharmaceutical
water, related substances, isomer,
moisture
Physicochemical
constant
Melting point, optical rotation,
refractive index, pH, viscosity,
particle size, crystalline form
Compound
discovery
Biomarkers, lead compounds, new
drug screening
Preclinical studies
Toxicology and pathology,
pharmacokinetics,
pharmacodynamics, formulation
Identification
Physical and chemical methods,
spectroscopy, chromatography,
mass spectrometry
Other
Method development, clinical
research

8. Product Service Test items Platforms
Biopharmace
utical
Content analysis
Protein, nucleic acid, O-acetyl, sialic acid, antigen,
bovine serum albumin, moisture, polysaccharide, other HPLC
LC-MS
Amino Acid Analyzer
Nucleic Acid Extractor
Microplate Reader
Electrothermal
Digestion Instrument
Microwave Synthesizer
Microbial related
indicators
Heat source, microbial limit, bacterial endotoxin,
abnormal toxicity
Limit detection
Preservatives, phenol, sodium chloride, tributyl
phosphate residues, pesticide residues, residual
solvents, antibiotic residues, related substances,
isomers, heavy metals
Omics research Metabolomics, genomics, proteomics
Molecular weight
Traditional
chinese
medicine
Limit detection
Spectroscopy, chromatography, mass spectrometry,
chemical methods, other
HPLC
HPLC-ELSD
FTIR
LC-MS
GC
Dumas Nitrogen
Analyzer
Sulfur Dioxide Analyzer
T860 Automatic Titrator
ABS
Flame Photometer
Atomic Absorption
Spectroscopy
Content analysis
Moisture, heavy metals, lead, cadmium, arsenic,
mercury, copper, ash, pesticide residues, aflatoxin,
sulfur dioxide, related substances, isomers,
magnesium iron salts, sodium, residual solvents, other
amino acids
Physicochemical
constant
Refractive index
Microbial related
indicators
Bacterial endotoxin, abnormal toxicity
Special substances and
groups
Oyster sauce
Preclinical study
Toxicology and pathology, pharmacokinetics,
pharmacodynamics, formulation
Identification
Physical and chemical methods, spectroscopy,
chromatography, mass spectrometry
Other Method development
Product Service Test items Platforms
Medicinal
excipients
Limit detection
Spectroscopy, chromatography, mass
spectrometry
GC
ICP-MS
XRF
HPLC
GC-MS
ABS
IC
Surface Tension Meter
Airflow Sieving Instrument
Total Organic Carbon Analyzer
Automatic Kjeldahl Analyzer
Content analysis
Moisture, heavy metals, arsenic salts, loss on
drying, ignition residue, easy carbides,
residual solvents, acid value, acetone
insolubles, related substances, clarity,
hydroxyl value, peroxide value, saponification
value, iodine value, fatty acids and esters
Physicochemical
constant
Melting point, pH, viscosity, solution color,
solubility
Identification
Physical and chemical methods, spectroscopy,
chromatography, mass spectrometry
Pharmaceutic
al packaging
materials
Microbial related
indicators
Microbial limit, abnormal toxicity GC-MS
T860 Automatic Titrator
HPLC
ICP-MS
ABS
GC
Microwave Digestion Instrument
Water Vapor Transmission Rate
Tester
Limit detection
Spectroscopy, chromatography, mass
spectrometry
Leachate Heavy metal, easy oxide, non-volatile
Mechanical property
Elongation, peeling strength, heat sealing
strength / heat bonding strength, impact
resistance, tear resistance, friction coefficient /
surface smoothness
Barrier performance Gas permeation, water vapor transmission
Other Thickness, density, etc.

9. Medical Device Testing
A medical device is an instrument, apparatus, implement, machine, implant,
in vitro reagent, or other similar article, that is intended for use in the
diagnosis, prevention and treatment of disease or other medical conditions.
To gain access to markets with the most rigorous standards for medical
devices and medical quality control, you need to ensure your products
maintain the highest standards. As a professional and comprehensive third-
party testing organization, Alfa Chemistry Testing Lab provides one-stop
testing, analysis and technical support services to clients around the world to
ensure the quality of medical devices, and issues authoritative, scientific, fair
and accurate testing reports for clients.
Industry Regulations
 U.S. Food & Drug Administration  International Organization for
Standardization
 ...... The European Union Medical Device
Regulation
Products Test service Regulations Platforms
Diagnostic equipment
Treatment equipment
Life support equipment
Medical monitors
Medical laboratory
equipment
Diagnostic medical
equipment
Accelerated aging shelf life
testing
ISO-10993
ISO-18562
ISO-1547
ISO-8536
USP <381>
USP <661>
USP <232>
GC
GC-MS
FTIR
UV/Vis
Spectrophotometry
ICP-MS
HPLC
SEC/ GPC
Container and package testing
Material analysis
Electrochemical corrosion
testing
EMC testing
Directive safety testing
Battery testing
Microbiological testing
Pin on disk wear testing
Porous coating testing
Wear testing
Regulatory services

10. 1-516-662-5404
info@alfa-chemistry.com
If you have any questions or would like to learn more about the
services that Alfa Chemistry Testing Lab offers for the
healthcare products, contact us at:
www.alfachemic.com/testinglab/industries/healthcare.html
2200 Smithtown Avenue, Room 1 Ronkonkoma, NY, USA
Healthcare
Products Testing
Services