Pharmaceutical Grade Sodium Hydroxide CP Edition Pharmacopoeia Quality Standard Medical Grade Sodium Hydroxide 500g per Bottle

Sodium hydroxide (NaOH), commonly known as caustic soda or lye, is a strong alkali widely used in the pharmaceutical industry. It not only acts as a catalyst in the synthesis of drugs but is also used to adjust the pH of medications and plays a crucial auxiliary role in certain drug formulations. Pharmaceutical grade sodium hydroxide must comply with the strict quality standards of the "Chinese Pharmacopoeia 2020 Edition" (CP Edition) to ensure its safety and effectiveness in pharmaceutical applications.

1. Appearance and Properties

Pharmaceutical grade sodium hydroxide should be white granules or crystals, odorless. It is hygroscopic in air, so it usually needs to be stored in sealed containers to maintain its dryness.

2. Identification

According to pharmacopoeia regulations, the identification methods for sodium hydroxide mainly include the following:

- Solubility test: When pharmaceutical sodium hydroxide dissolves in water, it should dissolve rapidly and release hydroxide ions, forming a strongly alkaline solution.

- Chemical reaction: Identification is carried out through the chemical reaction of sodium hydroxide with acids to form salts and water (acid-base neutralization reaction).

3. Assay

The pharmacopoeia requires that the content of pharmaceutical sodium hydroxide should be controlled between 95.0% and 102.0% (calculated on a dried basis). This standard ensures its purity, making it suitable for various uses in pharmaceutical processes, including pH adjustment, dissolution, and neutralization in formulations.

4. Moisture Content

The moisture content of pharmaceutical grade sodium hydroxide must be less than 1.0%, as it is prone to absorb moisture in humid environments, which can affect its stability and effectiveness. Therefore, strict control of moisture is crucial to ensuring product quality.

5. Heavy Metals

According to the "Chinese Pharmacopoeia 2020 Edition," the content of heavy metals (such as lead, cadmium, etc.) in pharmaceutical sodium hydroxide must not exceed 10 ppm. This standard ensures that the product does not contain heavy metal elements harmful to the human body.

6. Arsenic Salts

The arsenic salt content in sodium hydroxide must not exceed 2 ppm. This standard also aims to ensure the safety of the product and avoid potential poisoning risks.

7. Microbial Limits

Pharmaceutical sodium hydroxide must meet the microbial limits specified in the pharmacopoeia, including tests for total bacterial count, molds, and yeasts. Especially when used in sterile drug formulations, its microbial content must be within the allowable range.

Pharmaceutical Grade Sodium Hydroxide CP Edition Pharmacopoeia Quality Standard Medical Grade Sodium Hydroxide 500g per Bottle

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