Once the raw materials arrive at our facilities, cGMP regulations require that they be quarantined and tested before they are released into inventory. The type of testing required includes identity and potency, microbiological compliance, and heavy metal compliance.
To test for identity and potency, there must be an established methodology for testing the raw material ingredient. That methodology may exist in the U.S. Pharmacopeia or provided by some other credible source. Not only must that methodology be followed, but an authenticated sample of the ingredient (standard) will need to be used to validate a sample of the incoming raw material ingredient. The standard is used for comparison purposes. The raw material will be tested against the standard using appropriate laboratory equipment to see if it matches. Appropriate lab equipment may include Fourier Transform Infrared (FT-IR) Spectroscopy, Ultraviolet-visible (UV-VIS) Spectroscopy, Inductively Coupled Plasma – Mass Spectrometry (ICP-MS) and High-Performance Liquid Chromatography (HPLC). In this way, identity and potency can be established.
Once the raw materials arrive at our facilities, cGMP regulations require that they be quarantined and tested before they are released into inventory. The type of testing required includes identity and potency, microbiological compliance, and heavy metal compliance.
To test for identity and potency, there must be an established methodology for testing the raw material ingredient. That methodology may exist in the U.S. Pharmacopeia or provided by some other credible source. Not only must that methodology be followed, but an authenticated sample of the ingredient (standard) will need to be used to validate a sample of the incoming raw material ingredient. The standard is used for comparison purposes. The raw material will be tested against the standard using appropriate laboratory equipment to see if it matches. Appropriate lab equipment may include Fourier Transform Infrared (FT-IR) Spectroscopy, Ultraviolet-visible (UV-VIS) Spectroscopy, Inductively Coupled Plasma – Mass Spectrometry (ICP-MS) and High-Performance Liquid Chromatography (HPLC). In this way, identity and potency can be established.
Finally, heavy metal testing for lead, mercury, cadmium, and arsenic may also be conducted. SD Life Sciences tests for conformance to the strict limits found in the United States Pharmacopeia (USP). If you are marketing your product in California, the state’s Proposition 65 limits are associated with some hefty fines if your product fails to meet their more stringent heavy metal requirements.
Once the raw materials arrive at our facilities, cGMP regulations require that they be quarantined and tested before they are released into inventory. The type of testing required includes identity and potency, microbiological compliance, and heavy metal compliance.
To test for identity and potency, there must be an established methodology for testing the raw material ingredient. That methodology may exist in the U.S. Pharmacopeia or provided by some other credible source. Not only must that methodology be followed, but an authenticated sample of the ingredient (standard) will need to be used to validate a sample of the incoming raw material ingredient. The standard is used for comparison purposes. The raw material will be tested against the standard using appropriate laboratory equipment to see if it matches. Appropriate lab equipment may include Fourier Transform Infrared (FT-IR) Spectroscopy, Ultraviolet-visible (UV-VIS) Spectroscopy, Inductively Coupled Plasma – Mass Spectrometry (ICP-MS) and High-Performance Liquid Chromatography (HPLC). In this way, identity and potency can be established.
Finally, heavy metal testing for lead, mercury, cadmium, and arsenic may also be conducted. SD Life Sciences tests for conformance to the strict limits found in the United States Pharmacopeia (USP). If you are marketing your product in California, the state’s Proposition 65 limits are associated with some hefty fines if your product fails to meet their more stringent heavy metal requirements.
Once the raw materials arrive at our facilities, cGMP regulations require that they be quarantined and tested before they are released into inventory. The type of testing required includes identity and potency, microbiological compliance, and heavy metal compliance.
To test for identity and potency, there must be an established methodology for testing the raw material ingredient. That methodology may exist in the U.S. Pharmacopeia or provided by some other credible source. Not only must that methodology be followed, but an authenticated sample of the ingredient (standard) will need to be used to validate a sample of the incoming raw material ingredient. The standard is used for comparison purposes. The raw material will be tested against the standard using appropriate laboratory equipment to see if it matches. Appropriate lab equipment may include Fourier Transform Infrared (FT-IR) Spectroscopy, Ultraviolet-visible (UV-VIS) Spectroscopy, Inductively Coupled Plasma – Mass Spectrometry (ICP-MS) and High-Performance Liquid Chromatography (HPLC). In this way, identity and potency can be established.
Once the raw materials arrive at our facilities, cGMP regulations require that they be quarantined and tested before they are released into inventory. The type of testing required includes identity and potency, microbiological compliance, and heavy metal compliance.
To test for identity and potency, there must be an established methodology for testing the raw material ingredient. That methodology may exist in the U.S. Pharmacopeia or provided by some other credible source. Not only must that methodology be followed, but an authenticated sample of the ingredient (standard) will need to be used to validate a sample of the incoming raw material ingredient. The standard is used for comparison purposes. The raw material will be tested against the standard using appropriate laboratory equipment to see if it matches. Appropriate lab equipment may include Fourier Transform Infrared (FT-IR) Spectroscopy, Ultraviolet-visible (UV-VIS) Spectroscopy, Inductively Coupled Plasma – Mass Spectrometry (ICP-MS) and High-Performance Liquid Chromatography (HPLC). In this way, identity and potency can be established.
Finally, heavy metal testing for lead, mercury, cadmium, and arsenic may also be conducted. SD Life Sciences tests for conformance to the strict limits found in the United States Pharmacopeia (USP). If you are marketing your product in California, the state’s Proposition 65 limits are associated with some hefty fines if your product fails to meet their more stringent heavy metal requirements.
Finally, heavy metal testing for lead, mercury, cadmium, and arsenic may also be conducted. SD Life Sciences tests for conformance to the strict limits found in the United States Pharmacopeia (USP). If you are marketing your product in California, the state’s Proposition 65 limits are associated with some hefty fines if your product fails to meet their more stringent heavy metal requirements.
Once the raw materials arrive at our facilities, cGMP regulations require that they be quarantined and tested before they are released into inventory. The type of testing required includes identity and potency, microbiological compliance, and heavy metal compliance.
To test for identity and potency, there must be an established methodology for testing the raw material ingredient. That methodology may exist in the U.S. Pharmacopeia or provided by some other credible source. Not only must that methodology be followed, but an authenticated sample of the ingredient (standard) will need to be used to validate a sample of the incoming raw material ingredient. The standard is used for comparison purposes. The raw material will be tested against the standard using appropriate laboratory equipment to see if it matches. Appropriate lab equipment may include Fourier Transform Infrared (FT-IR) Spectroscopy, Ultraviolet-visible (UV-VIS) Spectroscopy, Inductively Coupled Plasma – Mass Spectrometry (ICP-MS) and High-Performance Liquid Chromatography (HPLC). In this way, identity and potency can be established.
Finally, heavy metal testing for lead, mercury, cadmium, and arsenic may also be conducted. SD Life Sciences tests for conformance to the strict limits found in the United States Pharmacopeia (USP). If you are marketing your product in California, the state’s Proposition 65 limits are associated with some hefty fines if your product fails to meet their more stringent heavy metal requirements.
The raw material must be tested for microbiological compliance to verify that it does not contain dangerous levels of microorganisms such as Salmonella, E. coli, yeast, or mold.
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