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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
Quality evaluation of Allopathic medicines
Quality evaluation of cosmetics/herbal cosmetics
Quality evaluation of Ayurvedic medicines
Quality evaluation of Homeopathic medicines
Shelf life / Stability studies of pharmaceutical products at both ambient and accelerated conditions as per ICH guidelines
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.
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
Topical semi-solids
Capsules (hard gelatin and soft gelatin) Pessaries
Creams
Powders  Gels
Gels
All type of veterinary products Ointments
Poultices
  Creams
Ointments
  Solutions
Pastes
  Ophthalmic Products
 
  Ointments
 
  Liquids  
     
Injections and Eye/Ear Drops Aerosols Oral Liquid
Small volume Injections (liquid and dry)
Sprays Syrup

Large volume injection

Foams Powder for Suspension
Implantations and infusions
  All type of veterinary products
Eye/ear drops
   
All type of veterinary products    
     
Herbal and Medicated Cosmetics Topical Liquids and Powders  
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
Identification
Uniformity of weight / mass / volume / fill etc.
Disintegration time
Dissolution Rate test
Uniformity of Content
Related substances
Presence of Steroids
Acid Value
Limit tests for heavy metal
Optical rotation
Refractive index
Melting point
Boiling point
Organic volatile impurities
Saponification value
Particulate Matter
Peroxide Value
Fatty acid and Esters
Particle Size
Residual SolventsPh
Presence of phytochemicals
Presence of Alkaloids
Iodine Value
Applicability
Tablets, Capsules, Powders
Dry syrups Parenteral / Non Parenteral Formulations
Tablets, Pessaries, Capsules
Injections, Oral liquids
Ayurvedic medicines, other medicines
Injections, Oral liquids
Ayurvedic medicines and other herbal products
Ayurvedic medicines and other herbal products
Raw materials as well as finished products
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)
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
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, Tablet
Applicability
Parenteral preparations (Injections, Sterile preparations for injections)
Systemic injection, intracutaneous injection, surgical items/ medical devices, plastic containers / rubber closures
Intravenous injections
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:
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
Environmental factors
Temperature
Light
Air
Oxygen
Moisture
Carbon dioxide
Other ingredients or excipients in the dosage form
Particle size of drug
pH of the vehicle
Microbial contamination
Trace metal Contamination
Leaching from containers
Condition of stability testing conduction
Shelf life storage stability
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.
 
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