For confirmatory studies, sample should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hour/ square meter to allow direct comparison to be made between drug substance & drug product.
Mack Pharmatech's Photostability Chambers are designed specifically to meet ICH & FDA requirement for Photostablity testing. Near UV & visible light testing is performed simultaneously according to Q1B option 2.
Established in the Year 1999, Our company shares a set of five core values : Integrity, Understanding, Excellence, Unity and Responsibility. These values, which have been part of our company’s beliefs and convictions from its earliest days, continue to guide and drive our business decision.
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