Potency

Potency Assay

Purpose - Determine concentration of active(s) in any of the following dosage forms; capsule, chew, cream, gel, injectable, lyophilized vial, nasal spray, ointment, ophthalmic, paste, pellet, powder, solution, suppository, suspension, tablet, trituration, or troche. USP <541><621>.

Sample Required (per active) - Minimum of 5 capsules, troches, or suppositories; or 5 mL for liquids and creams; or 1 g for powders.
These amounts may not always be practical, call if in doubt.

Turn Around - Results available within 7 business days

RUSH samples require an approved Rush Request form.
Refer to our API List for available test methods.

_{Additional costs may apply for certain API's and/or formulations.}

Potency Over Time

Purpose - Determines potency for stability studies. Can be assayed at any interval for any length of time and under the following storage conditions; Ambient (20º to 25ºC), Refrigeration (2º to 8ºC), or Frozen (-10º to -25ºC). USP <541><621>.

Sample Required - Same as Potency Assay, multiplied by anticipated number of tests requested (ie: 5 mL x 5 tests = 25 mL)

Turn Around - Results available within 3 days* from requested dates

_{* No testing is performed on weekends or holidays.
Additional costs may apply for certain API's and/or formulations.}

Phase 1 (SIA) Method Development and Validation

Purpose - Method(s) developed and validated, per <1225>, to extend BUD's per <795> <797> and FDA requirements. Involves forcibly degrading the sample using heat, light, acids, bases, and oxidizing agents and developing a validated method with proves that potential breakdown products will not interfere with the API(s) during the stability study being requested.

Sample Required - Minimum 250 mL or g, along with 50 mL or g of placebo (Defined in Quote)

Turn Around - Receipt of deposit ($2,000) and Consumables places formulation into SIA queue.

Phase 2 (BUD) Beyond Use Date Study

Purpose - Following the development and validation of method(s) performed during Phase 1 (SIA), a Stability Study using the SIA method(s) will be utilized to test the concentration of API(s) to establish the appropriate BUD, defined by <795> Table 4 or <797> Table 14.

Sample Required - Depends on established BUD protocol
(Defined in Quote)

Turn Around - Results available within 3 days* from requested dates.

_{* No testing is performed on weekends or holidays.
Additional costs may apply for certain API's and/or formulations.}

Controlled Room Temperature Storage

Purpose - Beyond standard Ambient (20º to 25ºC) storage, CIAL has Controlled temperature and humidity chambers (25ºC / 60% RH) to meet FDA, ICH requirements. USP <659>.

Sample Required - (Defined in quote)

Turn Around - Results available within 3 days from requested dates.

Accelerated Storage

Purpose - Accelerate stability testing by a factor of 2 to 3 fold. CIAL has an elevated temperature and humidity chamber (40ºC / 75% RH) to accelerate the testing of your room temperature samples. Note: This test will provide an approximate idea of stability but does not replace normal stability testing.

Sample Required - (Defined in quote)

Turn Around - Results available within 3 days from requested dates.

Minimum Fill

Purpose - Ensures that the labeled amount of product in a container confirms the labeled amount. The test applies to creams, lotions, ointments, pastes, etc. USP <755>.

Sample Required -  Test requires 10 filled containers.

Turn Around - Results available within 7 business days.

Uniformity of Dosage Units

Purpose - Determines the consistency of potency for each item, such as capsules, troches, or single dose syringes in a lot.  The test requires 10 items to be individually tested to be sure the potencies are within allowable tolerances.  A statistical calculation is used to determine acceptability. USP <905>.

Sample Required -  Minimum of 10 dosage units

Turn Around - Results available within 7 business days

Cleaning Validation (Surface Recovery)

Purpose - Determines the level of drug residue remaining on manufacturing or preparation surfaces after cleaning.  The test involves swabbing the test surface(s) then having the swab(s) tested to determine the amount of remaining residue. USP <800>.

Sample Required - 1 swab per surface tested, plus 4 blank swabs

Turn Around - Results available within 7 business days*

_{* Method Development charges may apply depending on detectable limit specifications.}

Identity by Retention Time

Purpose - Generally performed along with the test for potency, this test verifies the identity of an API by determining if the retention and UV spectrum (UHPLC) / molecular weight (LC-MS) of the sample matches that of the reference standard. USP <621>.

Sample Required - (Refer to Potency Assay)

Turn Around - Results available within 7 business days

_{* Will be charged at Potency Assay rate if potency testing is not performed.}

Dissolution Testing

Purpose - Determines the time required for relase of the active(s) from immediate or extended release dosage units (ie: capsules, tablets, sllw release formulations, etc). USP <711>.

Sample Required - (Defined in quote)

Turn Around - Results available within 10 business days*

_{* Method Development charges may apply if no method available (ie: USP monograph).}

Residual Solvents

Purpose - Determines the identity and quantity of solvent(s) present in an API that may remain from the manufacturing process. USP <467>.

Sample Required - (Defined in quote)

Turn Around - Results available within 10 business days*

_{* Method Development charges will apply for API's not listed in <467>.}