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Specifications of Croscarmellose Sodium丨CAS 74811-65-7
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Property |
Specification |
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Identification |
A. The Croscarmellose Sodium absorbs the methylene blue and settles as a blue, fibrous mass. B. Incline the test tube, and carefully add 2 mL of sulfuric acid down the side so that it forms a lower layer: a reddish-violet color develops at the interface. C. A portion of the mixture of Croscarmellose Sodium with water, prepared as directed in Identification B, imparts an intense yellow color to a nonluminous flame. |
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pH |
5.0 ~ 7.0 |
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Settling Volume |
The volume of the settled mass is 10.0 ~ 30.0 mL |
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Degree of Substitution |
0.60 ~ 0.85 on the dried basis |
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Sodium Chloride and Sodium Glycolate |
The sum of the percentages of sodium chloride and sodium glycolate: 0.5% max |
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Content of Water-Soluble Material |
10.0% max |
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Loss on Drying |
10.0% max |
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Residue on Ignition |
14.0% ~ 28.0% |
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Microbial Enumeration Tests and Tests For Specified Microorganisms |
The total aerobic microbial count: 1000 cfu/g max The total combined molds and yeasts count: 100 cfu/g max It meets the requirements of the test for absence of Escherichia coli. |
Transport Information of Croscarmellose Sodium丨CAS 74811-65-7
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Parameter |
Specification |
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UN Number |
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Class |
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Packing Group |
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H.S. Code |
2933990099306 |
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Stability & Reactivity |
Stable |
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Storage |
Store in a closed, dry, ventilated place |
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Condition to Avoid |
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Package |
Introduction of Croscarmellose Sodium丨CAS 74811-65-7
Croscarmellose Sodium丨CAS 74811-65-7 is a cross-linked polymer of carboxymethylcellulose, commonly used in the pharmaceutical and nutraceutical industries. It is widely recognized for its role as a superdisintegrant in tablet formulations. Here are the primary applications and benefits of croscarmellose sodium:
Applications of Croscarmellose Sodium丨CAS 74811-65-7
1. Pharmaceutical Industry:
- Tablet and Capsule Formulations: Croscarmellose Sodium丨CAS 74811-65-7 is used as a superdisintegrant in the manufacturing of tablets and capsules. It helps the tablet break down quickly when it comes into contact with moisture, ensuring rapid drug release and absorption.
- Orally Disintegrating Tablets (ODTs): It is particularly useful in ODTs, which are designed to dissolve in the mouth without the need for water, providing a convenient dosage form for patients who have difficulty swallowing pills.
- Wet Granulation and Direct Compression: Croscarmellose sodium is versatile and can be used in both wet granulation and direct compression tablet manufacturing processes.
2. Nutraceuticals:
- Dietary Supplements: Croscarmellose sodium is used in dietary supplement tablets to ensure that the active ingredients are quickly released and absorbed by the body.
3. Veterinary Medicine:
- Animal Tablets: Similar to its use in human medicine, croscarmellose sodium is used in veterinary tablets to ensure the quick disintegration and absorption of medications in animals.
Benefits of Croscarmellose Sodium丨CAS 74811-65-7
1. Enhanced Drug Release:
- Rapid Disintegration: The primary benefit of croscarmellose sodium is its ability to promote rapid disintegration of tablets, leading to quicker drug release and faster onset of action. This is especially beneficial for medications that need to work quickly, such as pain relievers or medications for acute conditions.
2. Improved Bioavailability:
- Better Absorption: By ensuring that the tablet disintegrates quickly, croscarmellose sodium helps improve the bioavailability of the active ingredients, meaning that a greater amount of the drug is absorbed into the bloodstream.
3. Patient Compliance:
- Ease of Swallowing: Tablets that disintegrate quickly are easier to swallow, which can improve patient compliance, particularly in populations like the elderly or children who may have difficulty swallowing traditional tablets.
4. Versatility in Formulations:
- Compatibility: Croscarmellose Sodium丨CAS 74811-65-7 is compatible with a wide range of active pharmaceutical ingredients (APIs) and excipients, making it a flexible choice for formulators in both pharmaceuticals and nutraceuticals.
- Low Use Levels: It is effective at low concentrations (usually 1-5% of the tablet weight), which minimizes its impact on the overall formulation while still providing effective disintegration.
5. Stability:
- Chemical Stability: Croscarmellose sodium is chemically stable and does not interact adversely with most APIs, ensuring the stability and integrity of the final product.
6. Cost-Effectiveness:
- Efficient Use: Its effectiveness at low concentrations makes it a cost-effective disintegrant, contributing to the economic efficiency of tablet and capsule production.
Precautions and Considerations:
1. Hygroscopic Nature:
- Moisture Sensitivity: Croscarmellose sodium is hygroscopic, meaning it absorbs moisture from the environment. This can lead to premature tablet disintegration if not properly stored. Tablets containing croscarmellose sodium should be stored in moisture-resistant packaging.
2. Not Suitable for All Formulations:
- Incompatibility with Certain APIs: Although generally compatible with most APIs, there can be specific cases where croscarmellose sodium may not be the best choice due to potential interactions or instability. Formulation studies are necessary to determine compatibility.
3. Regulatory Considerations:
- Quality Control: As with all pharmaceutical excipients, the quality and consistency of croscarmellose sodium must be carefully controlled to meet regulatory standards and ensure the safety and efficacy of the final product.
Conclusion:
Croscarmellose Sodium丨CAS 74811-65-7 is an essential excipient in the pharmaceutical industry, primarily used as a superdisintegrant in tablet and capsule formulations. Its ability to promote rapid disintegration and enhance drug release makes it invaluable for ensuring the efficacy and bioavailability of oral medications. Additionally, it is beneficial in improving patient compliance, especially in populations that have difficulty swallowing traditional tablets. However, proper storage and compatibility testing are important to ensure the stability and effectiveness of formulations containing croscarmellose sodium.
