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    Home » Services » Laboratory Testing Services » Pharmaceuticals Products Testing

    Pharmaceuticals Products Testing

    Pharmaceuticals Products Testing
    Pharmaceuticals Products Testing
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    Service Code : PPTS - 45

    Our company is acknowledged as one of the topmost companies, engaged in offering reliable Pharmaceuticals Products Testing services. Rendered in various pharmaceutical companies for stringently inspecting the efficacy, composition and the impact medicines on the human and animal health. This Pharmaceuticals Products Testing is carried out in our well equipped laboratory under the guidance of senior professionals.

    Features:

    • Tests the side effects of medicines, if any
    • Carried out in accordance with medical standards
    • Feasible rates are charged

    Drugs, Pharmaceuticals, Cosmetics & Herbal Products

    Health Care

    The section dealing with the drugs, pharma, cosmetics and herbal preprations focuses on the following thrust areas:

    • Quality evaluation of Allopathic medicines
    • 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

    Why is it necessary to analyze and certify drugs and pharmaceutical products ?

    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.

    What are the general nature of pharmaceutical samples taken for analysis at SRI ?
    Raw Materials

    Finished Products

    • Oral Solids
      Tablets (coated and uncoated)
      Capsules (hard shell and soft shell)
      Powders
    • Parenteral products
      Injections
      Implantations
    • Inhalation products
      Topical semi-solids
      Creams
      Gels
      Poultices
      Ointments
      Pastes
    • Topical Liquids and Powders
      Mechanical Contraceptives
      Condoms
      Tubal Rings
      Copper T
    • Oral Liquids
      Syrup
      Suspension
    • Aerosols
      Sprays
      Foams
    • Rectal and vaginal products
      Suppositaries
      Pessaries
      Gels
      Ointments
      Creams
      Solutions
      Ophthalmic Products
      Ointments
      Liquids
      Gels
    • Surgical items
      Sutures and ligatures
      Adhesive tapes
      Dressing and guages
    There are different sets of parameters for evaluating samples of different nature.
    What are the quality Norms and Protocols followed for analysis?
    Analysis is done as per both National and International Standards with following major 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 analysed by the methods developed by scientists of SRI.

     

    What are the general methods followed for various drugs and pharmaceutical products ?
    The general methods for various drugs and pharmaceutical products are as follows:

    • Physical
    • Chemical
    • Instrumental
    • Microbiological
    • Pharmacological

    What are the test parameters evaluated by using different methods ?

    In order to ensure the right quality of the products, besides testing for the active ingredients, it is also necessary to test several other parameters. For each parameter the protocols/validated methods are used. Following list gives the details of the parameters other than purity and their methods.

    J.K.LABORATORY 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 analysed using different methods :

    Using Physical Methods
    • Test Parameters
      Description Appearance, Colour, Odour, Shape
      Dimensions
      Tensile Strength / Minimum breaking load
      Adhesive strength
      Scouring loss
      Absorbancy
      Fracture test
      Friction force test
      Burst volume and pressure test
      Water leakage
      Pouch integrity
      Pouch burst strength
    • Applicability
      All raw materials and finished products
      Adhesive tapes, Dressing and guage, Sutures, Copper T, Tubal Rings, Condoms
      Adhesive tapes, Sutures, Copper-T
      Adhesive Tape
      Dressing and guage
      Dressing and guage
      Tubal rings
      Tubal rings
      Condoms
      Condoms
      Coppr-T
      Copper - T
    Using Chemical / Instrumental Methods
    • Parameters
      Identification
      Uniformity of weight / mass / volume / fill etc.
      Disintegration time
      Dissolution
      Uniformity of Content
      Related substances
      Presence of Steroids
    • pH
      Presence of phytochemicals
    • Presence of Alkaloids, Tannins
      Limit tests for heavy metals
      Optical rotation
      Refractive index
      Melting point
      Boiling point
      Organic volatile impurities
      Saponification value
      Acid Value
      Peroxide Value
      Fatty acid and Esters
      Particle Size
      Residual Solvents
    • Applicability
      All raw materials and finished products
      Tablets, Capsules, Powders / Dry syrups Parenteral / Non parenteral
      formulations
      Tablets, Pessaries, Capsules
      Tablets, Pessaries, Capsules
      Tablets, Capsules, Pessaries, Powders/ Dry Syrups, Injections, Oral liquids
      Injections, Tablets, Capsules, Powders/ Dry syrups, Oral liquids, Pessaries
      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
    • Applicability
      Antibiotics, Vitamins
      Parentaral Preparations (Injections, Sterile Preparation for Injections) Non Parentaral Preparations (Opthalmic Solutions, eye drops, Eye ointments) Surgical Dressing (Purified cotton, Guage, Guage-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, Tablets
      Raw materials, Tablets, Capsules, Oral Suspensions
    • Test Parameters
      Microbiological assays
      Sterility
      Microbial limit tests for Pathogenic organisms
      Lactic Acid Bacillus
    Using Pharmacological Methods
    • Test Parameters
      Pyrogen / Bacterial endotoxins
      Undue toxicity / abnormal toxicity
      Oxytocic activity
      Histamine like substances
    • Applicability
      Parenteral preparations (Injections, Sterile preparations for injections)
      Systemic injection, intracutaneous injection, surgical items/ medical devices, plastic containers / rubber closures.

      Intravenous injections

    What are the facilitites at J.K.LABORATORY ?

    J.K.LABORATORY is equipped with all facilities and has an animal house 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.

    Shelf Life / Stability Studies of Drugs and Pharmaceutical Products

    What is Shelf life in case of Health Care Products ?

    Shelf-life refers to the period from initial preparation and packaging during which the drug dosage form continues to remain within its physical, chemical, therapeutic and toxicological specifications at specified storage conditions.
    The product must retain 90% of the labeled claim at the end of shelf-life.

    What does stability mean for drugs and pharmaceuticals ?

    The stability of the product is its ability to resist deterioration. It is always expressed in terms of shelf life.

    As per USP there are five types of stability studies :

    • Chemical
    • Physical
    • Microbiological
    • Therapeutic
    • Toxicological

    What are the factors affecting Stability ?

    The various factors affecting pesticides stability are :

    • Environmental factors
    • Temperature
    • Light
    • Air
    • Oxygen
    • Moisture
    • Carbondioxide
    • Other ingredients or excipients in the dosage form
    • Particle size of drug
    • pH of the vehicle
    • Microbial contamination
    • Tracemetal Contamination
    • Leaching from containers

    When do we need stability testing ?
    How are the stability tests conducted ?

    • Studies are conducted at
    • Accelerated conditions
    • Controlled room temperature conditions
    • Product samples are analyzed at various intervals by validated analytical methods

    J. K. ANALYTICAL LABORATORY & RESEARCH CENTRE
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    We Provide Our Testing Services in India, Africa, USA, and Canada.

    All The Clients Are Requested To Send Their Samples Through Courier Only, As We Will Not Be Able To Entertain Any Client At The Lab.