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 1
$ 150

Method 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>
$ 70

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>
$ 175

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

$ 70

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 1a
$ 200

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 1 g 

Turn Around - Results available within 7 business days.

Loss on Drying

USP <731>
$ 120

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>
$ 90

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>
$ 120

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>
$ 175 / element

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>
$ 150

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>
$ 90

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>
$ 150

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>
$ 250

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>
$ 110

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>
$ 105

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>
$ 75

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.

ABSORBANCE OF SOLUTION / ABSORPTIVITY

USP <857>
$ 185