Test Services
Endotoxins are lipopolysaccharides (LPS) or lipooligosaccharides (LOS), found in the outer membrane of various Gram-negative bacteria. When injected into the body, they may cause anything from mild to severe inflammation, to in the most severe cases, septic shock. Presence of endotoxins in a compound is evidence of a current or previous contamination. Removal of endotoxins requires a specialized filtration system, and they are not removed by 0.2um filters used to sterilize compounded medications. Some typical sources of endotoxins are raw materials, water, instruments and reagents that are stored and used to compound, for example solutions used to adjust the pH of solution.
OUR METHODOLOGY
DYNALABS employs the kinetic chromogenic and photometric quantitative testing methodologies, the kinetic-chromogenic, and the kinetic-turbidimetric methodologies. Both technologies are sensitive down to 0.005 EU/mL. The test protocols are based on guidelines delineated in USP <85> Bacterial Endotoxins Test.
Samples are assayed in quadruplicate against a five standard curve run in duplicate. Two of the quadruplicate samples are spiked with a known amount of endotoxin that must recover within an acceptable range to verify that the sample is not inhibiting the test.
FORMS TESTED
- Oil Injections
- Aqueous Injections
- Suspensions
- Sterile Solutions
- Pellets
- Powders
Microbial identification becomes critically important when samples are found to be contaminated with a microorganism and/or if routine monitoring of the clean room or flow hoods results in organisms growing in or on test media. Identification of contaminating organisms assists in understanding probable sources of the contamination, which will help in preventing or at least minimizing future contaminations. Identification is also important in determining the “usual or resident” microorganisms in the facility, so if new organisms are identified as part of an investigation, the source of the contamination may be new and/or not associated with the facility, people and/or processes.
OUR METHODOLOGY
DYNALABS employs a number of methodologies from gram staining and microscopic inspection, to amplification of the DNA from contaminating organism(s). Results are reported based on the tests performed.
FORMS TYPICALLY TESTED
- Positive Media Fill Tests
- Bench and/or Hood Swabs
- Settling Plates
- Contaminated Samples
Particles measured by this test are defined as insoluble, free floating substances that cannot be measured by chemical means. The presence of particles in solutions and parenteral injections is an indication that the active(s) and/or excipient(s) may have precipitated or crystallized. It is critically important to determine the number and size of particles, because if present they may cause blockages that could be detrimental to the health of the patient.
OUR METHODOLOGY
DYNALABS employs two method of measuring particulate matter:
- USP <788> Light Obscuration Particle Count Test – Instrumental analysis using a laser to count and size each particle. Specifications relate to the size of the particle counted and the volume of the solution/injection being tested (see table below).
- USP <797> Physical Inspection – Visual inspection of the sample held up against a lighted white and black background as specified in Finished Preparation Release Checks and Tests Section. The specification for this test is absolute (i.e., None Detected).
| Volume | Allowable Limits | |
| ≥10 | ≥25 | |
| Less than 100mL | 6000/container | 600/container |
| Greater than 100mL | 25/mL | 3/mL |
FORMS TESTED
- Aqueous Injections and Solutions
- Oil Injections (Physical Inspection only)
- Medical Devices
Potency: A measure of the concentration, strength or activity of a medication. Potency is usually expressed as the amount of active pharmaceutical ingredient (API) within some unit measure of the medication, such as, but not limited to mg/mL, mg/gm, IU/mL, mg/capsule, mg/pellet etc., where the numerator is the amount API, and the denominator is the unit measure of the medication. Specifications for potency are typically expressed as a range, such as but not limited to 90.0 – 110.0% of label value. Purity: A measure of the pureness of a raw material. Purity is typically expressed as a percent of activity, and is most often used to determine the factor used to adjust for the amount of impurities within an API raw material. Specifications for Purity are also typically expressed as a range, albeit a narrower one, such as 98.5 – 101.5%
OUR METHODOLOGY
DYNALABS employs a number of technologies for testing potency. However, purity measures and stability studies are performed using technologies where the methods can be proven to be stability indicating (e.g., HPLC). Our list of potency/purity testing technologies, include but are not limited to, HPLC, LC-MS, GC, UV/VIS, NIR, and Titrations.
When testing for potency or purity, the concentration of the API is assigned a value based on prequalified, tightly controlled reference standards. Testing protocols are developed based on guidelines delineated in USP <621> Chromatography and USP <851> Spectrophotometry and Light-Scattering, and are validated according to USP <1225> Validation of Compendial Procedures and ICH Guidelines. The customer is notified immediately of any sample that does not test within acceptable limits.
FORMS TESTED
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The test for pH is to measure the acidity or basicity of an aqueous solution. The pH of water at 25°C is approximately 7.0. Solutions with a pH of greater than 7.0 are said to be basic and solutions with a pH of less than 7.0 are acidic.
OUR METHODOLOGY
DYNALABS tests pH using a standardized potentiometric instrument according to USP <791>. For samples with a monograph in the USP, DYNALABS will use the specification defined in the monograph, unless otherwise instructed by the customer. For samples that do not have monographs DYNALABS uses the customer-defined specification, and in the absence of a customer-defined specification will use a specification of “Report Result”.
FORMS TESTED
- Aqueous Injections and Solutions
Specific gravity is the ratio of the weight of a liquid, to that of an equal volume of water at the same temperature and barometric pressure. Specific gravity is commonly used in industry as a simple means of obtaining information about the concentration of solutions. It is also used when using weight to control volume. A specific gravity of greater than 1 means the solution is heavier than water, and conversely a specific gravity of less than 1 means the solution is lighter than water. A solution with a specific gravity of 1.0234 would mean that 100mL of the solution would weigh 102.34gms.
OUR METHODOLOGY
DYNALABS employs digital density meter technology for testing specific gravity. Test protocols are developed in accordance to USP <841> Specific Gravity. Samples are assayed in triplicate and results are reported to 4 decimal places.
FORMS TYPICALLY TESTED
- Liquids
- Oils
- Creams
- Ointments
- Gels
Sterility is a state of being free of microorganisms. Results are expressed as “No Turbidity Observed – Interim” for samples that are found to be free of microorganisms, or “Positive – XX” for samples that are found to contain microorganisms, where the “XX” represents the media in which the sample was found to be positive.
OUR METHODOLOGY
DYNALABS employs the Membrane Filtration methodology for testing sterility of compounded medications. The test protocol is based on guidelines delineated in USP <71> Sterility Tests.
The sample is split into two equal portions and each portion is transferred into one of two 0.2um filter canisters. A vacuum is applied to the canisters and the aqueous portion of the medication is filtered away. The canisters are then washed 3 times to remove any residual drug and preservative. One canister is filled with Tryptocase Soy Broth (TSB) and incubated at 22.5 ± 2.5⁰C. This media is designed to grow aerobic microorganisms and fungi. The second canister is filled with Fluid Thioglycollate Medium (FTM) and incubated at 32.5 ± 2.5⁰C. This media is designed to facilitate the growth of anaerobic and facultative anaerobes. Both canisters are incubated for 14 days. For turbid samples, a portion of the incubated media is transferred to fresh media on the 14th day and then incubated an additional 4 days.
Negative controls are run at the beginning and end of each batch of samples tested. All control and sample canisters are inspected every day, and the results updated according to the inspection findings. If any sample canister shows signs of growth the customer is notified immediately.
FORMS TESTED
- All Sterile Forms