Choose a topic to review acceptance criteria, documentation or testing arrangements.
Content and measurement
Agree the target content and its calculation basis in writing. Manufacturing guidance uses a nominal filling allowance of 105–110% for specified content, with adjustments for raw-material content and processing losses. The raw-material input may differ from the final assayed amount because of moisture, counterions and other components. Content results depend on reference standards, sampling and dissolution. Measurement uncertainty and filling variation are reviewed against the agreed specification. We confirm applicable production allowances during quotation rather than treating one percentage as a universal test tolerance.
For a verified content shortfall, compensation is proportional to the missing amount across the affected quantity. Fractional-box compensation may be settled by equivalent value. Content above the filling allowance does not qualify for compensation solely because of overfill. Unless a different target is disclosed and agreed before ordering, the stated purity target is at least 99% by HPLC. HPLC purity describes the main chromatographic peak proportion, distinct from content per vial. For an agreed 99% target, a qualifying result below 99% provides a 30% remedy. A result below 98% provides a 100% remedy with destruction evidence in photos or video. Settlement is confirmed through the documented review.
Specify endotoxin, heavy-metal, microbial, dissolution and solution-stability requirements before ordering. We confirm acceptance limits, methods, sample or batch and fees in writing. The raw-material endotoxin reference is below 10 EU/mg or the applicable supplier COA limit. Any stricter finished-product limit must be agreed and tested before dispatch. Supplier COAs retain their original issuer. Raw-material results apply to the material tested, while finished-vial claims require corresponding finished-sample testing. Endotoxin and microbial return eligibility requires the relevant test and acceptance limit to be agreed and verified before dispatch. Heavy-metal requirements must also form part of the order specification.
The manufacturing process described to us includes repeated vial washing, drying, heat treatment, stopper cleaning, filtration and environmental treatment. These controls alone do not establish finished-product sterility. Agree any sterility or microbial-limit test, acceptance criteria and pre-dispatch verification before ordering. Request the applicable process and testing details during specification review.
For aftercare assessment, the designated laboratories are Freedom or JANO. Agree the sample, batch and testing scope before commissioning. Discuss acceptance of other laboratories in advance. We may request a repeat test after an out-of-specification result and cover the agreed repeat-test cost. The qualifying repeat report is used to resolve the discrepancy. Reports commissioned for this review should identify SPECIVIS as the client. Historical supplier reports retain their original issuer and details. Keep original reports and traceable sample information.
Confirm the laboratory, sample, acceptance criteria, final fee and turnaround before commissioning. Fees are converted using the same reference rates as the product catalogue and rounded up to one decimal place.