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FSCC 22000
Food Safety Systems Certification
cGMP, GLP - FDA Approved, ISO 9001, ISO 14001, ISO 17025, ISO 45001, HACCP, FSSC 22000, FSSAI, "REACH" Registered, Kosher & Halal Certified. We observe WHO Good Manufacturing Practice GMP and Good Laboratory Practice GLP
Excellence in Excipients and API Manufacturing.DMF Support and Documentations Available
WHO-GMP Certified
Good Manufacturing Practice Certified by World Health Organization
WC, Written Confirmation
for Active Substance to be imported into European Union (EU).Lamivudine BP Ph Eur USP Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Lamivudine BP Ph Eur USP Grade and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
All technical documents and DMF support available.
Lamivudine SDS of Manufacturers
Synonyms: Lamivudine
CAS Number: 134678-17-4, Molecular Weight: 229.26, Chemical Formula: C8H11N3O3S, EINECS EC Number: 603-844-3, FEMA: NA,Lamivudine or 3TC is an antiviral medication used to treat chronic Hepatitis B (HBV) and HIV-1/HIV-2 infections, usually in combination with other antiretrovirals. It works as a nucleoside reverse transcriptase inhibitor (NRTI) to stop viral DNA replication.
General Properties and Specifications of Lamivudine or 3TC:
Appearance: White to Almost white powder or crystals.
Assay: >98%
Melting Point: 175C to 179C. Also reported is 160C to 162C. Literature.
Solubility: Soluble in water.
Storage: Heat Sensitive. Store at room temperature. Ideally refrigerate.
Lamivudine USP Grade Specifications:
C8H11N3O3S --- 229.26
C8H11N3O3S-0.2CH3OH 235.66
C8H11N3O3S-0.2H2O 232.86
2(1H)-Pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-, (2R -cis)-;
(–)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine CAS 134678-17-4
UNII: 2T8Q726O95DEFINITION
Lamivudine contains NLT 98.0% and NMT 102.0% of lamivudine (C8H11N3O3S), calculated on an anhydrous and solvent-free basis. If labeled as a methanol solvate, it contains NLT 98.0% and NMT 102.0% of lamivudine (C8H11N3O3S), calculated on anhydrous, methanol-free, and solvent-free basis.IDENTIFICATION
A. Infrared Absorption
B. The retention time of the major peak of the Sample solution corresponds to that of the System suitability solution, as obtained in the test for Limit of Lamivudine Enantiomer.
Assay: 98.0%–102.0% on the anhydrous, methanol-free, and solvent-free basis.
Content of Methanol (if labeled as lamivudine methanol solvate): To pass the test by chromatography.
Limit of Lamivudine Enantiomer: To pass the test by chromatography.
Other Related Compounds: To pass the test by chromatography.
Residual Solvents: To pass the test by chromatography.
Water Determination: NMT 2.0%
Light Absorption: To pass the test.
Packaging and Storage: Preserve in well-closed, light-resistant containers. Store at room temperature.
Lamivudine BP Ph Eur Grade Specifications:
C8H11N3O3S --- 229.3 CAS 134678-17-4
Action and use: Nucleoside reverse transcriptase inhibitor; antiviral.
Preparations: Lamivudine Tablets, Zidovudine and Lamivudine Tablets, Abacavir Zidovudine and Lamivudine Tablets, Abacavir and Lamivudine TabletsDEFINITION
4-Amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2(1H)-one.
Content: 97.5 per cent to 102.0 per cent (dried substance).CHARACTERS
Appearance: White or almost white powder.
Solubility: Soluble in water, sparingly soluble in methanol, slightly soluble in ethanol (96 per cent).IDENTIFICATION
First identification: B, C
Second identification: A, B
A. Specific optical rotation: -99 to -97 (dried substance). Dissolve 0.250 g in water R and dilute to 50.0 mL with the same solvent.
B. Infrared absorption spectrophotometry.
C. Enantiomeric purity (see Tests).TESTS
Absorbance: Maximum 0.3 at 440 nm, using a path length of 4 cm.
Dissolve 1.00 g in water, using sonication if necessary, and dilute to 20.0 mL with the same solvent.
Related substances: To pass the test by Liquid chromatography.
Enantiomeric purity: To pass the test by Liquid chromatography.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Storage: Protected from light.Keywords: Lamivudine IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 134678-17-4 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
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Manufacturer Supplier Exporter
ANMOL CHEMICALS Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 65290102, +91 22 65290103
Taloja Navi Mumbai, Banglore, INDIAe-mail: info@anmol.org
Copyright and Usual Disclaimer is Applicable
Last updated 31-may-26Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.
Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.
All products are Sold for Industrial and Laboratory Use only.
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BP Ph Eur Grade Manufacturers