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
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 :
- 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 |
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Raw Materials |
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Biological & Non Biological includes antibiotics steroids Hormones and sex Hormones
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Compressed Tables and Capsules
- Tablets (coated and uncoated)
- Capsules (hard gelatin and soft gelatin)
- Powders
- All type of veterinary products
Injections and Eye/Ear Drops
- Small volume Injections (liquid and dry)
- Large volume injection
- Implantations and infusions
- Eye/ear drops
- All type of veterinary products
Herbal and Medicated Cosmetics
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Rectal and Vaginal Products
- Suppositories
- Pessaries
- Gels
- Ointments
- Creams
- Solutions
- Ophthalmic Products
- Ointments
- Liquids
Aerosols
Topical Liquids and Powders
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External Applications-Products
- Topical semi-solids
- Creams
- Gels
- Poultices
- Ointments
- Pastes
Oral Liquid
- Syrup
- Powder for Suspension
- All type of veterinary products
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DTH quality Norms and Protocols
- Indian Pharmacopoeia
- United States Pharmacopoeia
- British Pharmacopoeia
- British Herbal Pharmacopoeia
- Ayurvedic Pharmacopoeia
- Unani Pharmacopoeia
- European Pharmacopoeia
- Martindales Extra Pharmacopoeia
- Any other protocol
In addition to this, products not listed in the pharmacopoeia are also analyzed by the methods developed by scientists of DTH.
General methods followed for drugs and pharmaceutical products
Physical, Chemical, Instrumental & Microbiological.
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:
Physical, Chemical, Instrumental & Microbiological Methods
Parameters
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Identification
- Uniformity of weight / mass / volume / fill etc.
- Disintegration time
- Dissolution Rate test
- Uniformity of Content
- Related substances
- Presence of Steroids
- Acid Value
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Limit tests for heavy metal Optical rotation Refractive index Melting point
Boiling point Organic volatile impurities Saponification valueParticulate Matter |
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Peroxide Value Fatty acid and EstersParticle Size Residual SolventsPh
Presence of phytochemicals Presence of Alkaloids
TanninsIodine Value |
Applicability
- Tablets, Capsules, Powders
- Dry syrups Parenteral / Non Parenteral Formulations
- Tablets, Pessaries, Capsules
- Injections, Oral liquids
- Ayurvedic medicines, other medicines
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Injections, Oral liquids
Ayurvedic medicines and other herbal productsAyurvedic medicines and other herbal productsRaw materials as well as finished products
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Using Microbiological Methods
Parameters
- Microbiological assays
- Sterility
- Microbial limit tests for Pathogenic organisms and their identifications
- monitoring of Sterile Area and clean area for bio-burden//Bacterial Endo toxins (LAL Test)
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Applicability
- Antibiotics(B lactam, Non B Lactam & Cephalosporines)
- Vitamins
- Parenteral Preparations (Injections, Sterile Preparation for Injections)
- Non Parenteral Preparations (Ophthalmic Solutions, eye drops, Eye ointments)
- Surgical Dressing (Purified cotton, Gauge, Gauge-Bandage, Sutures, Catgut
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- Sterilized devices (Gloves, Blades, Disposable Syringes,
Needles, Transfusion and Infusion assemblies - Mechanical Contraceptives
- Raw materials, Powders, Oral Suspensions, Creams,
Ointments, Lotions, Topical Solutions, Empty Capsule Shells, Tablets
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Applicability
- Parenteral preparations (Injections, Sterile preparations for injections)
- Systemic injection, intracutaneous injection, surgical items/ medical devices, plastic
containers / rubber closures
- 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
- Process Improvements
- Product Differentiation.
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.
As per USP; 4 types of stability studies:
Chemical, Physical, Microbiological, Toxicological
Factors affecting Stability
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Environmental factors
- Temperature
- Light
- Air
- Oxygen
- Moisture
- Carbon dioxide
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Other ingredients or excipients in the dosage formParticle size of drug
pH of the vehicleMicrobial contaminationTrace metal ContaminationLeaching from containers
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Condition of stability testing conduction
- Shelf life storage stability
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Accelerated conditions
- Controlled room temperature conditions
- Product samples are analyzed at various intervals by validated analytical methods
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.