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Methyldopate Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Methyldopate Hydrochloride USP CAS No: 2508- 79- 4

Batch No: MET/ 030313 A. R. No 13/ FP/ MET/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

Complies b) Chloride: Meets the requirements.

4. Related Substances

Individual Impurity Total Impurity

0.32 %

1.1%

NMT 0.5%

NMT 2.0%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +14.1º Between - 13.5° to - 14.9°

6. pH 3.4 Between 3.0–5.0

7. Loss on drying 0.23% NMT 0.5%

8. Heavy Metals Complies 10ppm

9. Residue On Ignition 0.07% NMT 0.1%

10. Assay HPLC 99.69% 98.0% –101.0%

.

Methyldopa

( S) - Methyldopa Structural Formulae V. 1. svg

Systematic ( IUPAC) name

( S) - 2- amino- 3- ( 3, 4- dihydroxyphenyl) - 2- methyl- propanoic acid

Clinical data

AHFS/ Drugs. com monograph

MedlinePlus a682242

Pregnancy

category

AU: A

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, IV

Pharmacokinetic data

Bioavailability approximately 50%

Metabolism Hepatic

Biological half- life 105 minutes

Excretion Renal for metabolites

Identifiers

CAS Registry Number 555- 30- 6 Yes

ATC code C02AB01

C02AB02 ( racemic)

PubChem CID: 38853

IUPHAR/ BPS 5217

DrugBank DB00968 Yes

ChemSpider 35562

UNII 56LH93261Y Yes

ChEMBL CHEMBL459

Chemical data

Formula C10H13NO4

Molecular mass 211.215 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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