| Drugs, Pharmaceuticals, Cosmetics & Herbal Products |
| The Company has complete in house facility to execute various jobs related to drugs, pharmaceuticals, cosmetics & herbal products |
| The section dealing with the drugs, pharma, cosmetics and herbal preparations focuses on the following as per DRUGS AND COSMETICS ACT 1945 AND THE RULES THEIR UNDER |
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Quality evaluation of Allopathic medicines |
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Quality evaluation of cosmetics/herbal cosmetics |
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Quality evaluation of Ayurvedic medicines |
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Quality evaluation of Homeopathic medicines |
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Shelf life / Stability studies of pharmaceutical products at both ambient and accelerated conditions as per ICH guidelines |
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Inspection services |
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| Requirement to analyze and certify drugs and pharmaceutical products as per DRUGS AND COSMETICS ACT 1945 AND THE RULES THEIR UNDER Analysis and certification of drugs and pharmaceuticals is necessary to ensure : |
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The conformity of healthcare products to the most critical standards of analysis. The chemical composition of the drugs to avoid any serious and adverse effects on human beings. |
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| Type of Products Analyzed at DTH |
| Raw Materials |
| Biological & Non Biological includes antibiotics steroids Hormones and sex Hormones |
| Compressed Tables and Capsules |
Rectal and Vaginal Products |
External Applications-Products |
| Tablets (coated and uncoated) |
Suppositories
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Topical semi-solids |
| Capsules (hard gelatin and soft gelatin) |
Pessaries
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Creams |
| Powders |
Gels
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Gels |
| All type of veterinary products |
Ointments
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Poultices |
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Creams
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Ointments |
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Solutions
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Pastes |
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Ophthalmic Products
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Ointments
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Liquids |
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| Injections and Eye/Ear Drops |
Aerosols |
Oral Liquid |
Small volume Injections (liquid and dry)
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Sprays |
Syrup |
Large volume injection
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Foams |
Powder for Suspension |
Implantations and infusions
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All type of veterinary products |
Eye/ear drops
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| All type of veterinary products |
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| Herbal and Medicated Cosmetics |
Topical Liquids and Powders |
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| DTH quality Norms and Protocols |
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Indian Pharmacopoeia |
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United States Pharmacopoeia |
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British Pharmacopoeia |
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British Herbal Pharmacopoeia |
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Ayurvedic Pharmacopoeia |
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Unani Pharmacopoeia |
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European Pharmacopoeia |
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Martindales Extra Pharmacopoeia |
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Any other protocol |
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| In addition to this, products not listed in the pharmacopoeia are also analyzed by the methods developed by scientists of DTH. |
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| General methods followed for drugs and pharmaceutical products |
| Physical, Chemical, Instrumental & Microbiological. |
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| What are the test parameters evaluated by using different methods? |
| DTH has all the facilities to take up the analysis of the above test parameters in different products as mentioned below. Parameters other than purity are analyzed using different methods: |
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| Physical, Chemical, Instrumental & Microbiological Methods |
| Parameters |
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Identification |
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Uniformity of weight / mass / volume / fill etc. |
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Disintegration time |
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Dissolution Rate test |
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Uniformity of Content |
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Related substances |
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Presence of Steroids |
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Acid Value |
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Limit tests for heavy metal |
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Optical rotation |
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Refractive index |
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Melting point |
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Boiling point |
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Organic volatile impurities |
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Saponification value |
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Particulate Matter |
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Peroxide Value |
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Fatty acid and Esters |
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Particle Size |
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Residual SolventsPh |
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Presence of phytochemicals |
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Presence of Alkaloids |
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Iodine Value |
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| Applicability |
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Tablets, Capsules, Powders |
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Dry syrups Parenteral / Non Parenteral Formulations |
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Tablets, Pessaries, Capsules |
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Injections, Oral liquids |
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Ayurvedic medicines, other medicines |
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Injections, Oral liquids |
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Ayurvedic medicines and other herbal products |
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Ayurvedic medicines and other herbal products |
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Raw materials as well as finished products |
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| Using Microbiological Methods |
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Microbiological assays |
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Sterility |
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Microbial limit tests for Pathogenic organisms and their identifications |
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monitoring of Sterile Area and clean area for bio-burden//Bacterial Endo toxins (LAL Test) |
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| Applicability |
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Antibiotics(B lactam, Non B Lactam & Cephalosporines) |
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Vitamins |
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Parenteral Preparations (Injections, Sterile Preparation for Injections) |
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Non Parenteral Preparations (Ophthalmic Solutions, eye drops, Eye ointments) |
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Surgical Dressing (Purified cotton, Gauge, Gauge-Bandage, Sutures, Catgut |
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Sterilized devices (Gloves, Blades, Disposable Syringes, |
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Needles, Transfusion and Infusion assemblies |
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Mechanical Contraceptives |
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Raw materials, Powders, Oral Suspensions, Creams, |
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Ointments, Lotions, Topical Solutions, Empty Capsule Shells, Tablet |
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| Applicability |
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Parenteral preparations (Injections, Sterile preparations for injections) |
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Systemic injection, intracutaneous injection, surgical items/ medical devices, plastic containers / rubber closures |
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Intravenous injections |
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| Facilitates at DTH |
| DTH is equipped with all facilities to take up the relevant test parameters for quality evaluation of different health care products. The details of the instruments are given in the list enclosed. The experts can not only develop validated methods for raw materials impurities and finished products but can also provide consultancy in the following areas: |
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Extraction of Herbal Products |
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Process Improvements |
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Product Differentiation |
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| Storage / Stability Studies of Drugs and Pharmaceutical Products |
| Shelf life refers to the period from initial preparation and packaging up to expiry date during which the drug dosage form continues to remain within its physical, chemical, and toxicological specifications at specified storage conditions. The product must retain the labeled claim weel within the limit mentioned for speified products under drug act and related Pharmacopoeia. |
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| As per USP; 4 types of stability studies: |
| Chemical, Physical, Microbiological, Toxicological |
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| Factors affecting Stability |
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Environmental factors |
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Temperature |
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Light |
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Air |
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Oxygen |
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Moisture |
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Carbon dioxide |
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Other ingredients or excipients in the dosage form |
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Particle size of drug |
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pH of the vehicle |
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Microbial contamination |
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Trace metal Contamination |
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Leaching from containers |
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| Condition of stability testing conduction |
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Shelf life storage stability |
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Accelerated conditions |
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Controlled room temperature conditions |
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Product samples are analyzed at various intervals by validated analytical methods |
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| Third Party Inspection |
| DTH undertakes third party inspection and testing of pharmaceutical supplies to various State Government Health Departments. The team of experts can undertake the inspection of different drugsandpharmaceuticalProducts. |
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