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.

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

Please submit a Rush Request form for RUSH samples or an API not found on our website API List.

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

Potency Over Time Stability

Purpose - Determine potency for Beyond Use Dating (BUD). Can be assayed at any interval for any length of time and under the following storage conditions; Room Temperature (20º - 25ºC), Refrigerator (2º - 8ºC), or Freezer (-10 to -25ºC).

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.

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

Stability Indicating Method Development

Purpose - Establish BUD per official USP, 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 (Stability Study using Stability Indicating Method).

Sample Required - Minimum 250 mL, along with 50 mL of placebo.
(Quote will outline extact amounts)

Turn Around - Depends on the complexity of the formulation and current workload. Receipt of deposit ($2,000) and Consumables places formulation into queue.

Stability Study using Stability Indicating Method

Purpose - Following development of the Stability Indicating Method, the Stability Study will use that method to periodically test the concentration of API(s) to establish the best BUD. This can be done for any dosage form.

Sample Required - Same as Potency Over Time Stability
(Please contact for exact quantity)

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

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

Controlled Room Temperature & Humidity Stability

Purpose - Beyond standard room temperature, CIAL has controlled temperature and humidity chambers (25ºC/60% R.H.) to meet FDA, ICH requirements.

Sample Required - (Refer to Potency Assay)

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

Accelerated Stability

Purpose - Accelerate stability testing by a factor of approx. 2 to 3 fold. CIAL has an elevated temperature and humidity chamber (40ºC/75% R.H.) 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 - (Refer to Potency Assay)

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 essentially the same for each.  If there is greater variability than allowed, then 20 items must be tested. A statistical calculation is used to determine acceptability. USP <905>

Sample Required -  Minimum of 10 dosage units (Requires Quote)

Turn Around - Results available within 7 business days.

Cleaning Validation

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 (Requires Quote)

Turn Around - Results available within 7 business days.

Identity by UHPLC Retention Time

Purpose - Generally performed along with the test for potency via UHPLC, this test verifies the identity of an API by determining if the retention and UV spectrum of the sample matches that of the reference standard. Performed per USP monograph.

Sample Required - (Refer to Potency Assay)

Turn Around - Results available within 7 business days.