Special Chemistries
Particulates
Purpose - Determines the number of subvisible particles in parenterals and ophthalmic in specified ranges: ≥10µm, ≥25µm, ≥50µm.
Method 1 - Light Obscuration and Validation
Method 2 - Microscopic
Sample Required - Minimum of 25 mL. The quantity of containers needs to be statistically representative of sampling the lot and based upon past history of particulate issues.
Turn Around - Results available within 7 business days.
Particulates
USP <788> <789> Method 1Method 2* - $300
* Requires previous Method 1 testing
pH
Purpose - Determines the pH of the sample to make sure it falls within the desired range for safety and stability.
Sample Required - 1 container (3 mL mimimum)
Turn Around - Results available within 7 business days.
pH
USP <791>Container Closure 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 within 7 business days.
Container Closure Integrity
USP <1207.2>Verified by <381>
Additional +$20 per container
Appearance
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 - 1 container
Turn Around - Results available within 7 business days.
Appearance, Odor, Color
Requires protocol
Water Determination
Purpose - Determines the water content, via Karl-Fischer, in an Active Pharmaceutical Ingredient (API). Must be Methanol Soluble. Can determine % water over a range of 1% to 100%. It is specific for water and should not be confused with Loss on Drying (LOD).
Sample Required - Minimum of 1 g
Turn Around - Results available within 7 business days.
Water Determination
USP <921> Method 1aLoss 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 1 g
Turn Around - Results available within 7 business days.
Loss on Drying
USP <731>Identity by Infrared
Purpose - Determines or confirms the identity of a single liquid or solid ingredient by producing an infrared spectral "fingerprint". This is then compared to a stored library of known ingredient spectra.
Sample Required - Minimum of 5 mg or 0.1 mL (more is desirable)
Turn Around - Results available within 5-7 business days.
Identity by Infrared
USP <197A>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 5 mL or 5 g (more is desirable)
Turn Around - Results available within 5-7 business days.
Identity by UV/VIS
USP <197U>Metals Analysis
Purpose - Determines the amount 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 5 mL, 5 g, or 2 capsules (more is desirable)
Turn Around - Results available within 5-7 business days.
Metals Analysis
USP <730> <230>Viscosity
Purpose - Determines the ability of a formulation to adhere to a surface, such as skin, eyes, or sinuses. It also determines its ability to suspend solid particles of active ingredients for uniform dosing.
Sample Required - Minimum of 20 mL or 20 g
Turn Around - Results available within 5-7 business days.
Viscosity
USP <912>Specific Gravity
Purpose - Provides information on weight vs. volume and enables conversion from one to the other. This makes it possible to formulate ingredients more conveniently and accurately. It also enables the pharmacist to prescribe by volume, those formulations which have been made by weight.
Sample Required - Minimum of 6 mL for liquids or 25 mL for creams/semi-solids (more is desirable).
Turn Around - Results available within 5-7 business days.
Specific Gravity
USP <841>Melting Point
Purpose -The melting point or melting range of an API is often used for identification as well as to check for purity according to the USP monograph. USP <741>
Sample Required - Minimum of 1 g (more is desirable)
Turn Around - Results available within 5-7 business days.
Melting Point
USP <741>Residue On Ignition / Sulfated Ash
Purpose - Determines the total level of inorganic impurities in an API according to the USP monograph. This test involves heating the sample in a furnace to burn off all organic substances, leaving only inorganic ash. USP <281>
Sample Required - Minimum of 2 g (more is desirable)
Turn Around - Results available within 5-7 business days.
RESIDUE ON IGNITION / SULFATED ASH
USP <281>Chemical Identification
Purpose -Verifies the presence of a chemical substance in an API by means of a chemical reaction. Examples: Chloride, Sodium, Acetate, Citrate, etc. USP <191>
Sample Required - Minimum of 50 mg (more is desirable)
Turn Around - Results available within 5-7 business days.
CHEMICAL IDENTIFICATION
USP <191>Optical Rotation
Purpose - Tests for purity and identity of optically active (chiral) APIs. Examples: Levo or Dextro rotary actives (L-Carnitine) USP <781S>
Sample Required - Minimum of 1 g (more is desirable)
Turn Around - Results available within 3-5 business days.
OPTICAL ROTATION
USP <781S>Crystalinity
Purpose -Characterizes compliance of crystalline APIs under polarized light, according to the individual monograph. USP <695>
Sample Required - Minimum of 10 mg (more is desirable)
Turn Around - Results available within 3-5 business days.
CRYSTALINITY
USP <695>Absorbance of Solution / Absorptivity
Purpose -Determines the quantity of a UV active ingredient in a formulation containing a single active ingredient. USP <857>
Sample Required - Minimum of 100 mg (more is desirable)
Turn Around - Results available within 5-7 business days.