Special Chemistries

Container Closure Integrity

Purpose - Test the integrity of the container closure sytem by dye intrusion technique to determine its ability to keep the medication safe and maintain sterility. Required for extending BUD's, per<795>, and multi-dose containers, per <797>. The amount of sample to be tested should be be statistically representative of the total lot / batch. USP <1207.2>.

Sample Required - Minimum of 4 filled containers (2 containers tested, 1 positive and 1 negative control)

Turn Around - Results available within 7 business days

pH

Purpose - Determines the pH of the sample to make sure it falls within the desired range for safety and stability. USP <791>.

Sample Required - 1 container (5 mL mimimum)

Turn Around - Results available within 7 business days

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

Water Determination (Karl Fischer)

Purpose - Karl Fisher titration determines the water content in an API powder or lyophilized product. Must be soluble in alcohol. This test specific for water, and not be confused with Loss on Drying (LOD). USP <921>*.

Sample Required - Minimum of 1 g 

Turn Around - Results available within 7 business days

_{* CIAL defers to Method 1a  (Direct Titration)}

Loss on Drying

Purpose - Determines % volatile substances in an active ingredient or formulated product. This could include residual solvents, as well as water. USP <731>.

Sample Required - Minimum of 1 g 

Turn Around - Results available within 7 business days

Identity by Infrared (FT-IR)

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. USP <197A>*.

Sample Required - Minimum of 10 mg or 1 mL (more is desirable)

Turn Around - Results available within 7 business days

_{* CIAL defers to Atenuated Total Reflection (ATR) analysis, per <197A>. Additional costs may apply for certain API's.}

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. USP <197U>.

Sample Required - Minimum of 50 mg or 1 mL (more is desirable)

Turn Around - Results available within 7 business days

Metals Analysis (ICP-OES)

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. USP <730>.

Sample Required - Minimum of 1 g or 5 mL

Turn Around - Results available within 7 business days

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. USP <912>.

Sample Required - Call CIAL for volume* needed

Turn Around - Results available within 7 business days

_{* Amount based on expected viscosity (cP).}

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. USP <841>.

Sample Required - Minimum of 10 mL

Turn Around - Results available within 7 business days

Melting Point / Range

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 100 mg (more is desirable)

Turn Around - Results available within 7 business days

Residue on Ignition

Purpose - also known as "Sulfated Ash", this test 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

Turn Around - Results available within 10 business days

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 100 mg (more is desirable)

Turn Around - Results available within 7 business days

Optical / Specific 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 100 mg (more is desirable)

Turn Around - Results available within 5 business days

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 5 business days

Microscopic Examination of Unknown Substance

Purpose - Under high magnification of up to 12,500x this service can be ordered to investigate unknown substances, such as microscopic particles to determine their identity and possible source.

Sample Required - Minimum 1 container

Turn Around - Results available within 3 business days

Visible Particulates

Purpose - Checks for the presence of visible particulates in sterile parenteral solutions by visualizing against a black and white background. This is particularly useful during stability studies of sterile products. USP <790>.

Sample Required - Minimum of 10 containers

Turn Around - Results available within 5 business days