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Cyclosporin Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Cyclosporin CAS No:

Batch No: CYC/ 011114 A. R. No 14/ FP/ CYC/ 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 crystalline powder

2. Solubility Complies Complies

3. Identification Complies Complies

4. Loss on drying 0.7% NMT 2.0%

5. Heavy metals 0.002% NMT 0.002%

6. Related substances

Individual impurity

Sum of all impurity

Other impurity

0.4%

1.2%

0.06%

NMT 0.7%

NMT 1.5%

NMT 0.1%

7. Residual solvents

Acetone

Ethanol

Acetic acid

Ethyl acetate

0.29%

0.00%

0.07%

0.01%

NMT 0.5%

8. Assay 99.9% 98.5% to 101.5%

Ciclosporin

Ciclosporin. svg

Ciclosporin- A- neutron- 3D- sticks. png

Systematic ( IUPAC) name

( 3S, 6S, 9S, 12R, 15S, 18S, 21S, 24S, 30S, 33S) - 30- Ethyl- 33- [ ( 1R, 2R, 4E) - 1- hydroxy- 2- methyl- 4- hexen- 1- yl] - 6, 9, 18, 24- tetraisobutyl- 3, 21- diisopropyl- 1, 4, 7, 10, 12, 15, 19, 25, 28- nonamethyl- 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31- undecaazacyclotritriacontane- 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32- undecone

Clinical data

Trade names Neoral, Sandimmune

AHFS/ Drugs. com monograph

MedlinePlus a601207

Pregnancy

category

AU: C

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral, IV, ophthalmic

Pharmacokinetic data

Bioavailability Variable

Metabolism Hepatic CYP3A4

Biological half- life Variable ( about 24 hours)

Excretion Biliary

Identifiers

CAS Registry Number 59865- 13- 3 Yes

ATC code L04AD01 S01XA18

PubChem CID: 5284373

IUPHAR/ BPS 1024

DrugBank DB00091

ChemSpider 4447449 Yes

UNII 83HN0GTJ6D Yes

KEGG D00184 Yes

ChEMBL CHEMBL160 Yes

Chemical data

Formula C62H111N11O12

Molecular mass 1202.61 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 7, 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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