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Metformin Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name METFORMIN HYDROCHLORIDE CAS No: 1115- 70- 4

Batch No: MET/ 011114 A. R. No 14/ FP/ MET/ 0111

Date of Manufacture Nov- 2014 Date of Analysis 02- 11- 14

Batch Quantity 100 kg Date of Retest Jan- 2017

Sr. No Test Results Acceptance Criteria

1. Appearance complies White to off white crystalline powder

2. Identification

B: IR- spectrum

E: reaction of chlorides

Complies

Consistent with the spectrum of metformin- hydrochloride CRS. ( 2.2.24)

It gives reaction of chlorides. ( 2.3.1)

3. Appearance of solution clear and colorless Clear( 2.2.1) and colorless( 2.2.2 Method II)

4. Related substances

Cyanogunadine( imp. A)

Any other impurity

Total impurities

0.002%

0.005%

0.02%

NMT0.02%

NMT 0.05%

NMT 0.2%

5. Assay( on dry basis) 99.8% 98.5% to 101.0%

6. Heavy metals 10 PPM

NMT 10 PPM

7. Loss on drying 0.05% NMT 0.5%

8. Sulphated ash 0.02% NMT 0.1%

9. Residual solvents

Methanol

475 PPM

NMT 3000 PPM

Metformin. svg

Metformin- from- xtal- 3D- balls. png

Systematic ( IUPAC) name

N, N- Dimethylimidodicarbonimidic diamide

Clinical data

Pronunciation / mɛ tˈ fɔ rmɨ n/ , met- fawr- min

Trade names Glucophage

AHFS/ Drugs. com FDA Professional Drug Information

MedlinePlus a696005

Licence data US FDA: link

Pregnancy

category

AU: C

US: B ( No risk in non- human studies)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration oral

Pharmacokinetic data

Bioavailability 50–60% [ 1] [ 2]

Protein binding Minimal[ 1]

Metabolism Not by liver[ 1]

Biological half- life 4- 8.7 hours[ 1]

Excretion Urine ( 90% ) [ 1]

Identifiers

CAS Registry Number 657- 24- 9 Yes

ATC code A10BA02

PubChem CID: 4091

IUPHAR/ BPS 4779

DrugBank DB00331

ChemSpider 3949 Yes

UNII 9100L32L2N Yes

KEGG D04966 Yes

ChEBI CHEBI: 6801 Yes

ChEMBL CHEMBL1431 Yes

Chemical data

Formula C4H11N5

Molecular mass 129.16364 g/ mol


Company Contact:


  • Phone: 912406641875

  • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

  • Email: Email


Published date: September 10, 2015 -

  • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

    Pharmaceuticals of global quality standards to Pharma Companies all over

    the world. In our warehouse facilities, approved by FDA. we supply

    Pharmaceutical Finished products, Dental products and Active

    Pharmaceutical Ingredients.

    We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

    We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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