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What is CAS Number
9 Jul 2024

What is CAS Number for Active Pharmaceutical Ingredients?

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A CAS Number, assigned by the Chemical Abstracts Service, is a unique numerical identifier for chemical substances, including active pharmaceutical ingredients (APIs). It consists of three groups of numbers separated by hyphens and can be up to 10 digits long. The format is:

  • First part: up to 7 digits
  • Second part: 2 digits
  • Third part: 1 digit (check digit)

CAS number is also commonly denoted as CAS#

For example, the CAS# for Velpatasvir 1377049-84-7.

Significance of CAS Numbers:

  1. Unique Identification: Each CAS number is unique to a specific chemical substance, ensuring precise identification.
  2. Standardization: Provides a standardized way of referring to chemicals, avoiding ambiguities associated with chemical names.
  3. Database Search: Facilitates easy and accurate search in chemical databases, ensuring researchers and professionals can access relevant information quickly.
  4. Regulatory Compliance: Essential for compliance with regulations as regulatory bodies require CAS numbers in documentation for chemical substances.

Generation of CAS Numbers:

CAS numbers are assigned by the Chemical Abstracts Service when a new chemical substance is reported in the literature or registered. The process involves:

  1. Chemical Submission: A new substance is described in a published journal or patent.
  2. Verification: CAS verifies the structure and assigns a unique number.
  3. Database Entry: The new CAS number and corresponding substance details are added to the CAS Registry.

Case Study: CAS Number and API Sourcing

API: Atorvastatin (used for lowering cholesterol)

  • CAS Number: 134523-00-5
  • Usage: Atorvastatin is widely used in pharmaceutical formulations to manage cholesterol levels and prevent cardiovascular diseases.

Importance in API Sourcing:

  1. Precision: The CAS number ensures precise identification of atorvastatin among thousands of other substances.
  2. Supplier Verification: Helps in verifying suppliers, ensuring the API sourced is correct and meets required standards.
  3. Regulatory Documentation: CAS# is used in regulatory submissions, ensuring compliance with international guidelines like the US FDA, EMA, and others.
  4. Quality Control: Facilitates quality control and assurance processes, ensuring the consistency and purity of the sourced API.

Example Scenario:

A pharmaceutical company, XYZ Pharma, is looking to source atorvastatin for their cholesterol-lowering medication. The procurement team uses the CAS number 134523-00-5 to search for reliable suppliers.

  1. Database Search: They use chemical databases such as SciFinder or ChemSpider to identify potential suppliers who provide atorvastatin with this CAS number.
  2. Verification: The team verifies the supplier credentials, quality certifications, and regulatory compliance using the CAS number.
  3. Quality Check: Upon receiving samples, they perform a series of analytical tests (like HPLC, NMR) to confirm the substance’s identity and purity against the specifications for the CAS# 134523-00-5.
  4. Regulatory Submission: When preparing regulatory documents for drug approval, the CAS number is included to ensure accurate identification and compliance with guidelines.

In conclusion, CAS numbers are crucial in the pharmaceutical industry for the precise identification, sourcing, and regulatory compliance of active pharmaceutical ingredients. By using CAS numbers, companies can ensure they procure the correct substance, maintain quality standards, and meet regulatory requirements effectively.

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