The Chemical Solutions™ PQ kit materials are NIST traceable.
Compliance with USP protocols is demonstrated by the user and not the kits themselves. Specific chapters in the USP refer to procedures and the HSQ™ Kit materials can be used as part of your protocol to meet the relevant USP requirements.
For example, the MicroSolv UV and HPLC performance qualification kits can be used to comply with USP <1058> or USP <857> regarding the qualification of instruments.
The new USP <857> standard requires agreement to < 0.01 AU but does not provide guidance on how to achieve this. Unfortunately most routine spectrophotometers cannot achieve 0.01 AU accuracy. Only very high-quality, research-grade UV VIS instruments can routinely meet this standard. This kit can be used to qualify the instrument since the materials are NIST traceable; However, if adhering to USP 857, additional work beyond the scope of the kit will be required. While the provided solutions can assist, external calculations must be performed to ensure USP compliance.
Click HERE for PQ & HSQ ordering information and pictures of the products. Chemical Solutions™ Qualification products are manufactured by MicroSolv.
