Pharmacopoeia quality standards for pharmaceutical-grade injectable mannitol, medical-grade mannitol with drug approval number as an active pharmaceutical ingredient.

Pharmacopoeia Quality Standards for Pharmaceutical-Grade Injectable Mannitol, Medical-Grade Mannitol API with Drug Approval Number

Pharmaceutical-grade injectable mannitol plays a crucial role in clinical treatment, with its quality standards strictly adhering to pharmacopoeia regulations to ensure safe and effective medication use. Additionally, due to its unique pharmacological properties, it demonstrates broad medical applications across various healthcare fields.

Pharmacopoeia Quality Standards

1. Characteristics

The Chinese Pharmacopoeia specifies that mannitol is a white crystalline powder, odorless, with a sweet taste. It is highly soluble in water, slightly soluble in ethanol, and almost insoluble in ether. Its melting point ranges from 166 to 170°C, and these physical characteristics serve as important initial indicators for assessing mannitol quality. Mannitol injection should appear as a clear, colorless liquid; any turbidity or discoloration indicates non-compliance with quality standards.

2. Identification

Chemical Identification: Take approximately 0.5g of mannitol, place it in a test tube, add 3ml of acetic anhydride, and slowly add 1ml of pyridine. Mix well and heat in a water bath for 30 minutes with occasional shaking. Allow to cool, then pour into 20ml of ice water. Rub the inner wall of the container with a glass rod to induce crystallization. Filter, wash the crystals with 5ml each of water and ethyl acetate, then add about 10ml of a 1:1 mixture of ether and ethyl acetate. Warm to dissolve, allow to cool, and let stand for crystallization. Dry the crystals at 90°C and determine the melting point, which should be between 120 and 125°C. Additionally, take 1ml of a saturated aqueous solution of mannitol, add 0.5ml each of ferric chloride test solution and sodium hydroxide test solution, which should produce a brownish-yellow precipitate that does not disappear upon shaking. Add an excess of sodium hydroxide test solution, and the precipitate should dissolve into a brown solution.

Spectral Identification: The infrared absorption spectrum of mannitol should match the reference spectrum, further confirming the correctness of its chemical structure through spectral analysis.

3. Testing

Acidity: Dissolve 5.0g of mannitol in 50ml of freshly boiled and cooled water, add 3 drops of phenolphthalein indicator solution and 0.30ml of sodium hydroxide titration solution (0.02mol/L). A pink color should appear, indicating that the acidity is within the acceptable range.

Clarity and Color of Solution: Dissolve 1.5g of mannitol in 10ml of water. The solution should be clear and colorless. If turbidity is observed, compare it with Turbidity Standard Solution No. 1; it should not be more turbid, ensuring no visible particles or turbidity affect drug quality and safety.

Impurity Testing: Strict limits are set for impurities such as chlorides, sulfates, oxalates, loss on drying, residue on ignition, heavy metals, and arsenic salts. For example, for chlorides, test 2.0g of mannitol as specified and compare with a control solution made from 6.0ml of standard sodium chloride solution; it should not be more concentrated (0.003%). For sulfates, test 2.0g as specified and compare with a control solution made from 2.0ml of standard sulfate solution; it should not be more concentrated (0.01%), etc.

4. Assay

Take approximately 0.2g of mannitol, accurately weighed, and place it in a 250ml volumetric flask. Add water to dissolve and dilute to volume, mixing well. Precisely measure 10ml, place it in an iodine flask, and accurately add 50ml of sodium periodate solution (prepared by mixing 90ml of sulfuric acid solution (1→20) with 110ml of sodium periodate solution (2.3→1000)). Heat in a water bath for 15 minutes, allow to cool, add 10ml of potassium iodide test solution, stopper tightly, and let stand for 5 minutes. Titrate with sodium thiosulfate titration solution (0.05mol/L) until near the endpoint, then add 1ml of starch indicator solution and continue titration until the blue color disappears. Correct the titration results with a blank test. Each 1ml of sodium thiosulfate titration solution (0.05mol/L) is equivalent to 0.9109mg of C₆H₁₄O₆, ensuring precise determination of mannitol content within the specified range of 98.0% to 102.0%.

Pharmacopoeia Quality Standards for Pharmaceutical-Grade Injectable Mannitol, Medical-Grade Mannitol API with Drug Approval Number

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Also available for consultation: Food-grade extracts, reagents, intermediates, cosmetic raw materials, export products.

Common dermatological active pharmaceutical ingredients mainly include the following categories:
1. Antifungal Drugs
- Ketoconazole: Used to treat fungal infections such as tinea corporis and tinea cruris.
- Terbinafine: Suitable for fungal infections like onychomycosis and athlete's foot.
- Clotrimazole: Commonly used for fungal infections of the skin and mucous membranes.
2. Antibiotics
- Mupirocin: Used to treat bacterial skin infections such as impetigo.
- Clindamycin: Suitable for acne and bacterial infections.
- Erythromycin: Used to treat acne and other bacterial infections.
3. Anti-inflammatory Drugs
- Hydrocortisone: Used to relieve skin inflammation and itching.
- Dexamethasone: Used to treat inflammatory skin conditions like eczema and dermatitis.
- Triamcinolone Acetonide: Suitable for eczema, psoriasis, etc.
4. Antiviral Drugs
- Acyclovir: Used to treat herpes simplex and shingles.
- Famciclovir: Suitable for shingles and genital herpes.
5. Antiparasitic Drugs
- Permethrin: Used to treat scabies and lice infections.
- Lindane: Suitable for scabies and lice.
6. Keratolytics
- Salicylic Acid: Used to treat acne, psoriasis, and corns.
- Urea: Suitable for dry skin and hyperkeratosis.
7. Immunomodulators
- Tacrolimus: Used to treat atopic dermatitis.
- Pimecrolimus: Suitable for eczema and dermatitis.
8. Vitamins
- Tretinoin: Used to treat acne and psoriasis.
- Vitamin D3 Analogs: Such as calcipotriol, used to treat psoriasis.
9. Others
- Benzoyl Peroxide: Used to treat acne.
- Sulfur: Suitable for acne and seborrheic dermatitis.
These active ingredients are typically applied to the skin in forms such as creams, ointments, gels, or solutions, and specific usage should follow medical advice.