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 x5 for capsules, tablets, etc; 5mL for liquids and creams; or 1GM for powders.
(May not always be practical; call to verify othewise)

Turn Around - Results available in 5-7 business days
(Call ahead for RUSH services or for actives not on our API List)

Additional costs may apply for certain API's and/or formulations

Potency Assay

USP <621> <797>
$ 165 and up

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 Temp (20ºC), Refrigerator (8ºC), Freezer (-20ºC), and Incubator (40ºC).

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

Turn Around - Results available ±3 days from requested dates
(Lab report in chart form, adding new data at each time point)

Additional costs may apply for certain API's and/or formulations

Potency Stability

USP <621> <797>
$ 165 and up

Accelerated Potency Stability

Purpose - Accelerate stability testing by ~2-3 fold. This is done using an elevated temperature (40ºC) and humidity chamber to help accelerate the testing time of samples normally stored at Room Temp.

Sample Required - Same as Potency Over Time Stability

Turn Around - Results available in ±3 days from requested dates

Accelerated Stability

USP <621> <797>
$ 235 / API (per test)

API Powder Assay

Purpose - Determine the potency and identity of the pure Active Pharmaceutical Ingredient (API).

Sample Required - Minimum of 1GM*
(May not always be practical; call to verify otherwise)

Turn Around - Results available in 5-7 business days
(Call ahead for RUSH services of for active not on our API List)

*Can test as little as 50MG if shipped in #3 capsule shell

API Powder

USP <621> <797>
$ 300 / API

Stability Indicating Method Development

Purpose - Determine BUD per official FD, California, and potential new USP <795><797> 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 100ML or 100GM
(Please contact for exact quantity)

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

Stability Indicating Method Development

USP <621> <797> <1225>
$ 9,500 and up

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 in ±3 days from requested dates

Additional costs may apply for certain API's and/or formulations

Stability Study using Indicating Method

USP <1225>
$ 165 and up

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.

Sample Required -  Minimum of 30 dosage units

Turn Around - Results available in 5 business days

Uniformity of Dosage Units

$ TBD

Please call for Quote


Cleaning Validation

Purpose - Determines to 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.

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

Turn Around - Results available in 5 business days

Validation cost ($330) waived if Surface Recovery Validation is performed in tandem

Cleaning Validation

$ 165 / surface

+ $330 Validation Cost


Surface Recovery Validation

Purpose - Determines the accuracy of the Cleaning Validation test. This test involves dosing a known low level concentration of an active ingredient onto surface(s) similar to those which will undergo the Cleaning Validation test. After being allowed to dry, the surface(s) are then swabbed and tested to determine recovery.

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

Turn Around - Results available in 5 business days

Validation cost ($330) waived if Cleaning Validation is performed in tandem

Surface Recovery Validation

$ 165 / surface

+ $330 Validation Cost