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API
Benefiting from the rapid growth of China's economy and the reform of the medical system, API manufacturers in China have rapidly improved their process technology, production quality, and registration and certification capabilities in the drug administration market, and their production scale continues to increase.
China's API products can be generally divided into three categories of bulk APIs, Featured APIs and patented APIs: (1) Bulk APIs include anti-infectives, vitamins, hormones and other large tonnages that do not involve patent issues Traditional chemical API. (2) Featured APIs include specialty chemical APIs represented by antihypertensive, antitumor, central nervous and hypoglycemic, which are mainly used to produce generic drugs whose patents are due or are about to expire, and have broad development prospects. (3) Patented pharmaceutical raw materials refer to the pharmaceutical active ingredients used in the manufacture of original drugs (patented drugs or innovative drugs), which mainly meet the clinical research, registration approval and commercialization of innovative drugs of international original drug companies and emerging biopharmaceutical companies. Demand at various stages of chemical sales, which also includes advanced intermediates that are used to produce the API but need to be supervised by regulatory authorities.
  • Fusidic acid
    Product Information Product name Fusidic acid; Fusidine CAS No. 6990-06-3 Molecular Formula C31H48O6 Molecular Weight 516.719 Quality Standard 97.5% up by HPLC Appearance White or almost white, crystalline powder COA ANALYSIS SPECIFICATION RESULTS Appearance White or almost white, crystalline powder White crystalline powder Solubility Practically insoluble in water, freely soluble in ethanol (96%) Practically insoluble in water, freely soluble in ethanol (96%) Identification IR: IR absorption spectrum of sample is in identical with that of reference substance IR absorption spectrum of sample is in identical with that of reference substance Reaction of sodium:  The residue does not give reaction (a) of sodium The residue does not give reaction (a) of sodium Water 1.4%-2.0% 1.7% Sulfated ash ≤0.2% 0.1% Assay (on anhydrous basis) 97.5% - 101.0% 99.9% Particle size 90% Particle diamite < 20 μm 100% Particle diamite < 20 μm Related substance Impurity M ≤ 1.0% 0.1% Impurity G ≤ 0.7% Not detected Impurity L ≤ 0.5% Not detected Impurity B ≤ 0.4% Not detected Impurity A ≤ 0.3% Not detected Impurity H ≤ 0.10% Not detected Impurity C ≤ 0.2% Not detected Impurity D ≤ 0.2% Not detected Impurity F ≤ 0.2% Not detected Impurity I  ≤ 0.2% Not detected Impurity K ≤ 0.2% Not detected Impurity K ≤ 0.2% Not detected Max unknown impurity ≤ 0.10% Not detected Total impurities ≤ 2.0% 0.1% Residual solvents Ethanol ≤ 5000pm Not detected Methanol ≤ 3000pm Not detected Ethyl acetate ≤ 5000pm Not detected N-hexane ≤ 290pm Not detected Microbial limit Bacteria ≤ 100cfu/g Not detected Total molds and yeasts ≤ 10cfu/g Not detected Staphylococcus aureus: None Not detected Pseudomonas aeruginosa: None Not detected Conclusion The sample complies with EP. Usage The application of Fusidic acid: Fusidic acid is primarily used as an antibiotic to treat bacterial infections. It is commonly applied topically, as a Fusidic acid cream or Fusidic acid ointment, to treat skin infections such as impetigo, infected cuts or wounds, and infected eczema. In some cases, it may also be prescribed orally or intravenously to treat systemic infections, particularly those caused by Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA). Additionally, fusidic acid has been used in combination with other medications for the treatment of various infections. For example, it may be combined with corticosteroids to treat inflammatory skin conditions or with hydrocortisone to treat otitis externa (outer ear infections). Fusidic acid works by inhibiting bacterial protein synthesis, specifically targeting the ribosomes within bacterial cells. This mechanism of action makes it effective against a wide range of bacteria, particularly Staphylococcus species. However, it is important to use fusidic acid judiciously to prevent the development of antibiotic resistance. *Products under the patent are only for R&D use

    Tags : Fusidic acid Fusidine 6990-06-3 Fusidic acid China Fusidic acid factory Fusidic acid manufacturer

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  • 34580-14-8
    Product Information   Product name Ketotifen hydrogen fumarate CAS No. 34580-14-8 Molecular Formula C23H23NO5S Molecular Weight 425.505 Quality Standard 98.5% up by HPLC Appearance White to brownish-yellow, fine crystalline powder   COA   ANALYSIS SPECIFICATION RESULTS Appearance White to brownish-yellow, fine crystalline powder Almost white fine crystalline powder Identification The infrared absorption spectrum of the sample is concordant with the reference standard Conforms Clarity and colour of solution The solution is clear and not more intensity coloured than reference solution Y4, BY4 or B4. Conforms Loss on drying ≤0.5% < 0.1% Sulfated ash ≤0.1% < 0.1% Assay(Titration) ≤20ppm <20ppm Related substances (by HPLC) Impurity A ≤ 0.2% 0.06% Impurity G ≤ 0.15% <LOD Any unspecified impurity ≤ 0.10% <LOD Total impurities ≤ 0.3% 0.06% Conclusion The product complies with R1-CEP 2004-269-Rev 01   Usage   What is Ketotifen fumarate? Ketotifen hydrogen fumarate is an antihistamine and mast cell stabilizer medication. It's primarily used to manage allergic conditions such as allergic conjunctivitis (itchy, watery eyes due to allergies) and asthma.   Its functions include:   Antihistamine: Ketotifen works by blocking the effects of histamine, a substance produced by the body during an allergic reaction. By inhibiting histamine, it helps alleviate symptoms like itching, redness, and swelling.   Mast Cell Stabilization: It also stabilizes mast cells, which are involved in allergic reactions. Mast cells release histamine and other inflammatory substances when triggered by allergens. Ketotifen helps prevent these cells from releasing these substances, reducing the severity of allergic reactions.   Ketotifen is available in various forms, including eye drops for allergic conjunctivitis and oral preparations for asthma and other systemic allergic conditions. As with any medication, it's essential to use Ketotifen as prescribed by a healthcare professional to achieve the best results and minimize potential side effects. *Products under the patent are only for R&D use

    Tags : ketotifen hydrogen fumarate powder ketotifen fumarate powder Ketotifen 34580-14-8 Ketotifen powder Ketotifen supplier

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