Special Chemistries

Particulates

Purpose - Determines the number of subvisible particles in parenterals and ophthalmic in specified ranges: ≥10µm, ≥25µm, ≥50µm

Sample Required - Minimum of 4ML in one container (syringe, vial, IV Bag, etc). Quantity of containers needs to be statistically representative of sampling the lot and based upon past history of particulate issues.

Turn Around - Results available in 2-3 business days

Particulates

USP <788> <789> Method 1
$ 100

pH

Purpose - Determines the pH of the sample to make sure it falls within desired range for safety and stability.

Sample Required - Minimum of 1ML (more is desirable)

Turn Around - Results available in 2-3 business days

pH

USP <791>
$ 50

Container Enclosure Integrity

Purpose - Test the container integrity by dye intrusion technique to determine its ability to keep the medication safe and maintain sterility. This test can also substitute for a Sterility <71> test at the end of a Stability Study.

Sample Required - Minimum of 4 filled containers (syringe, vial, pump, jar, etc)

Turn Around - Results available in 2-3 business days

Container Enclosure Integrity

USP <1207.2> Verified by <381>
$ 150

Appearance, Odor, Color

Purpose - Describes the sample as received and can be done periodically throughout a Stability Study. Can be used to document the condition of the formulation over time.

Sample Required - Minimum of 5ML or 5GM (more is desirable)

Turn Around - Results reported as samples are tested (±2 days*)
*CIAL is closed weekends and holidays

Appearance, Odor, Color

$ 50

Water Determination

Purpose - Determines the water content, via Karl-Fischer, in an active ingredient, lyophilized product, solid, or liquid dosage form*.  Must be Methanol Soluble.  It is specific for water and should not be confused with Loss on Drying (LOD). Can determine % water over a range of 1% to 100%.

Sample Required - Minimum of 0.5GM (more is desirable)

Turn Around - Results available in 2-3 business days

*Not compatible with oily or greasy formulations

Water Determination

USP <921> Method 1a
$ 150

Loss on Drying

Purpose - Determines % volatile substances in an active ingredient or formulated product. This would include residual solvents, as well as water.

Sample Required - Minimum of 1GM (more is desirable)

Turn Around - Results available in 2-3 business days

Loss on Drying

USP <731>
$ 95

Identity by Infrared

Purpose - Determines or confirms the identify of a single liquid or solid ingredient by producing an infrared spectral "finger print". This is then compared to a stored library of known ingredient spectra.

Sample Required - Minimum of 5MG or 0.1ML (more is desirable)

Turn Around - Results available in 2-3 business days

Identity by Infrared

USP <854>
$ 65

Identity by UV/VIS

Purpose - Determines identity and, in some cases of simple mixtures, can be used to quantify active ingredients using UV and Visible wavelengths of light.

Sample Required - Minimum of 5ML or 5GM (more is desirable)

Turn Around - Results available in 2-3 business days

Identity by UV/VIS

USP <857> <1207.2>
$ 100

Metals Analysis

Purpose - Determines amounts of single or multiple metals in an active ingredient or formulated product. Metals such as: Sodium, Potassium , Copper, Zinc, Magnesium, or organometallic compounds (such as Copper Gluconate) can be assayed.

Sample Required -Minimum of 5ML, 5GM, or 2 capsules (more is desirable)

Turn Around - Results available in 2-3 business days

Metals Analysis

$ 150 / metal