Standard -Draft - Copper sulfate pentahydrate
Version 1 February 2006
1. Description: the material shall consist of cupric sulfate [copper (II) sulfate, CuSO4.5H2O] pentahydrate together with related manufacturing impurities and shall be a blue crystalline material.
2. Common Name: Copper sulfate pentahydrate
3. Chemical Name (IUPAC): Copper (II) sulfate pentahydrate, cupric sulfate pentahydrate
4. CAS Number: 7758-99-7
5. Identity test: identity of the active constituent must be established by atomic absorption spectroscopy or colorimetric method or any other suitable test method.
6. Composition
6.1 Active constituent: Copper sulfate pentahydrate content: 980 g/kg minimum (equivalent to 250 g/kg as total copper).
6.2 Impurities:
Arsenic: maximum 0.1 x X mg/kg, where X is the copper content found under 6.1 (Note 1)
Lead: maximum 0.5 x X mg/kg, where X is the copper content found under 6.1 (Note 2)
Cadmium: maximum 0.1 x X mg/kg, where X is the copper content found under 6.1 (Note 3).
7. Analytical methods
- The analytical method used for the determination of the active constituent and toxicological significant impurities must be validated in accordance with the APVMA guidelines for the validation of analytical methods.
- The APVMA guidelines on validation of analytical methods state that “Analytical methods described in CIPAC handbooks and AOAC International Manual, and in recognized pharmacopoeias [BP, BP (Vet), Ph Eur and USP] for a particular active constituent or formulation are regarded as validated and do not require revalidation. However, the suitability of these methods must be verified under actual conditions of use i.e., the selectivity and accuracy of the method should be demonstrated for the published method when applied to the relevant sample matrix and laboratory conditions.
- When a CIPAC or AOAC method is used for the assay of an active constituent in a bulk active constituent, there is no matrix. The registrants need to check the specificity of the method to ensure there is no interference from impurities or degradation products. However, determination of accuracy of the method is not required as there is no matrix effect. However, when a CIPAC or AOAC method is used for the assay of an active constituent in a formulated product, determination of both specificity and accuracy is required as the matrix is relevant in formulated products (formulated products have different composition and quantities of excipients).
- Refer to Guidelines for the Validation of Analytical Methods for Active Constituent, Agricultural And Veterinary Chemical Products (PDF, 164kb).
- Unless the scope of the collaborative method (CIPAC and AOAC) also includes toxicological significant impurities in the active constituent, validation data for impurities are required.
AOAC: Association of Official Analytical Chemists (The Official Methods of Analysis)
CIPAC: Collaborative International Pesticides Analytical Council
Note 1 On a found content of 250 g/kg total copper, the maximum permitted amount of arsenic would be 0.1 x 250 = 25 mg/kg in the technical material.
Note 2 On a found content of 250 g/kg total copper, the maximum permitted amount of lead would be 0.5 x 250 = 125 mg/kg in the technical material.
Note 3 On a found content of 250 g/kg total copper, the maximum permitted amount of cadmium would be 0.1 x 250 = 25 mg/kg in the technical material.