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Published by ccm, 2019-05-16 05:18:55

AYUSH Brochure 18-12-18

AYUSH Brochure 18-12-18

Keywords: AYUSH,Herbal,Research,Testing,Pharma

AYUSH LICENCE NO. GATL/03

AYUSH Testing Services

(FDCA License No.: GTL/37/31) (No.Certi/GLP/Accuprec/2015/SC-2/32202/B) (Regi. No. 1709/PO/Rc/S/13/CPCSEA) ISO 9001: 2015 NABL ISO/IEC (LICENCE NO. : GATL/03)
Registered (Certificate No. TC - 6124) 17025:2005
Accredited
(Certificate No. 2017-HK-0010)
(Certificate No. 201710-01)

1 Physico-Chemical Testing Services

(as per Ayurvedic Pharmacopoeia of India)

 Acid insoluble ash  Nutri onal value analysis
 Acid Value  Op cal rota on
 Alcohol Soluble extrac ve value  Peroxide Value
 Alcohol Content  pH determina on
 Alkaloid analysis  Phenol content
 Boiling Point  Protein Es ma on
 Congealing range  Reducing Sugars
 Detec on of Mineral Oil  Refrac ve Index
 Determina on of Viscosity  Residual solvent analysis
 Ether Soluble Extrac ve Value  Saponifica on Value
 Fa y oil  Specific Gravity
 Foreign Ma er  Starch es ma on
 Iodine Value  Sulphated Ash
 Limit Test  T.L.C
 T.S (Microscopical Iden fica on)
• Arsenic  Tannin content
• Chloride  Total Ash
• Iron  Total Solids
• Lead  Vola le Oil in Drugs
• Sulphates  Water Soluble Extrac ve value
 Mel ng Range  Water Insoluble Ma er
 Moisture Content  Water Soluble ash
 Non-Reducing Sugars

2 Microbiological Testing of 3 Heavy Metals &

AYUSH Formulations Toxin Analysis

 Escherichia coli  Limit test
 Pseudomonas aeruginosa  Heavy metals by ICP-OES
 Salmonella  Aflatoxins
 Shigella  Qualita ve and Quan ta ve
 Staphylococcus aureus
 Bile-Tolerant Gram nega ve bacteria analysis of Pes cide residues
 Specified organism(s) test
 Total Aerobic Plate Count
 Yeast and mold plate count

4

Phyto-chemical services

 Development of herbal formula ons
 Extrac on, frac ona on and characteriza on of phyto-cons tuents using

modern sophis cated technologies like FTIR, NMR, MS, GC-MS, LC-MS, etc.
 Es ma on of phytochemicals
 Standardiza on of herbal as well as Ayurvedic medicine
 Valida on of Ayurvedic Medicine

5

Pre-clinical & Toxicological services

 An Cancer Ac vity (In - Vitro/ In Vivo)
 An HIV Ac vity
 Bio - Analy cal Study
 CNS, CVS, An -diabe c Ac vity, An obesity Ac vity
 Customized Screening of Services
 Development of Animal Screening Models
 Screening of Analgesic, An - Inflammatory and An - Arthri c Ac vity
 Toxicological Studies (As per OECD and Schedule Y Guidelines)

6

Clinical Services

 Clinical site management as per requirement by the sponsor.
 Clinical Trial of Phase II, III and IV for Herbal Drugs as per

schedule Y, ICMR and ICH-GCP guidelines
 Prepara on of Clinical trial Protocol for Herbal Drug and

Regulatory Approval there of

7

Research & Formulation Development Services

 Controlled Release and Sustained Release formula ons
 Excipients Compa bility Selec on and Op miza on
 Op miza on of Exis ng Formula ons
 Tech Transfer and Commercial Produc on Support
 Design & Development of Innova ve & patentable Herbal formula on
 Isola on, Purifica on & Characteriza on of Pharmaceu cal and Herbal
 Nano technology based Nano formula on, Nano Neutraceu cals and Nano based

Cosme cs.

8

Regulatory Dossier & IP Management Services

 Patent Search, Dra ing & Filling
 Trademark Search & Filling Services
 Industrial Design Search & Filling Services
 Copyright Filling Services
 Technology transfer & License agreements.
 Prepara on of CTD & e-CTD Dossier for

countries like USA, Canada, Europe, Brazil
 Prepara on of Dossier for Herbal

Formula ons

AYUSH LICENCE NO. GATL/03


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