Pharmacopoeia Standard Interpretation Sample of Pharmaceutical-Grade Mannitol for Injection and Oral Use, Packed 500g per Bag

Interpretation of Pharmacopoeia Standards for Pharmaceutical Grade Mannitol Injection/Oral Bulk API - Sample Pack 500g per Bag

Pharmaceutical-grade injectable mannitol plays a critical role in clinical treatment. Its quality standards strictly adhere to pharmacopoeia regulations to ensure medication safety and efficacy. Additionally, owing to its unique pharmacological properties, it demonstrates broad medical applications across various healthcare fields.

Pharmacopoeia Quality Standards

1. Description

The Chinese Pharmacopoeia specifies that mannitol should appear as a white crystalline powder, odorless with a sweet taste. It is readily soluble in water and slightly soluble in ethanol. Its melting point ranges from 166 to 170°C. These physical characteristics serve as important preliminary indicators for assessing mannitol quality. Mannitol injection should be a clear, colorless liquid. Any presence of turbidity or discoloration indicates non-compliance with quality standards.

2. Identification

Chemical Identification: Place approximately 0.5g of mannitol in a test tube, add 3ml of acetic anhydride, and slowly add 1ml of pyridine dropwise. 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 warm to dissolve. Allow to cool and stand for crystallization. Dry the crystals at 90°C and determine the melting point, which should be between 120 and 125°C. Alternatively, take 1ml of a saturated aqueous solution of mannitol, add 0.5ml each of ferric chloride test solution and sodium hydroxide test solution. A brownish-yellow precipitate will form, which does not disappear upon shaking. Upon adding excess sodium hydroxide test solution, the precipitate dissolves, forming a brown solution.

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

3. Tests

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 titrant (0.02mol/L). A pink color should develop, 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 intense, ensuring no visible foreign matter or turbidity affects drug quality and usage safety.

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

4. Assay

Weigh accurately about 0.2g of mannitol and place it in a 250ml volumetric flask. Dissolve in water and dilute to volume, mixing well. Precisely measure 10ml, transfer to an iodine flask, and accurately add 50ml of sodium periodate solution (prepared by mixing 90ml of 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 titrant (0.05mol/L). As the endpoint approaches, 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 titrant (0.05mol/L) is equivalent to 0.9109mg of C₆H₁₄O₆, enabling precise determination of mannitol content to ensure it complies with the specified range of 98.0% to 102.0%.

Interpretation of Pharmacopoeia Standards for Pharmaceutical Grade Mannitol Injection/Oral Bulk API - Sample Pack 500g per Bag

Below are some common dermatological active pharmaceutical ingredients (APIs) and pharmaceutical excipients:
Dermatological APIs:
1. Calcium Gluconate: Reduces capillary permeability, used as adjunctive therapy for allergic conditions such as urticaria, eczema, and pruritus.
2. Benzoic Acid: Functions as a preservative and is also used in pharmaceuticals and dye carriers. In dermatological preparations, it is commonly employed as a preservative to prevent microbial growth.
3. Chloramphenicol: An antibiotic used for skin infections like impetigo and folliculitis, offering antibacterial and anti-inflammatory effects.
4. Urea: Acts as a keratolytic agent, enhancing skin moisture, and is used to treat dry skin and fissures.
Dermatological Pharmaceutical Excipients
1. Dimethyl Sulfoxide: Serves as a solvent and penetration enhancer, facilitating drug absorption through the skin. It also possesses anti-inflammatory and analgesic properties.
2. Sodium Bisulfite: A pharmaceutical excipient used as an antioxidant in dermatological preparations to prevent drug oxidation.
3. White Petroleum Jelly: Functions as an ointment base and lubricant, forming a protective film on the skin to prevent water loss and provide moisturizing and protective effects.
4. White Beeswax: Can be used as an ointment base and release retardant, modulating drug release rates.
5. Cross-Linked Sodium Carboxymethyl Cellulose: Acts as a thickener and disintegrant, increasing formulation viscosity and stability.
6. Povidone-Iodine: An antiseptic and disinfectant used for purulent dermatitis, skin fungal infections, minor burns, and disinfection of mucosal wounds.
7. Calamine: Has astringent and protective properties, commonly used in dermatological external preparations like lotions and liniments to treat eczema and dermatitis.
8. Zinc Oxide: Provides astringent, antipruritic, and skin-protective effects, often combined with other drugs to treat various skin conditions such as eczema and prickly heat.
9. Glycerin: A humectant that absorbs moisture from the air, maintaining skin hydration and preventing dryness.
10. Cream Base: Serves as a base for ointments, ensuring even distribution of the drug on the skin for easy application and efficacy.