We offer the highest quality in science-based microbiological and chemistry testing. The experience and knowledge of our team combined with state-of-the-art equipment makes EAGLE the best choice for all your testing and consulting needs.
Please contact Client Care or complete and submit the pricing request form for the most up-to-date information on our testing and consulting services and for assistance with submitting a sample via EagleTrax. We look forward to serving you.
Client Care Pricing Request Form Consulting Services Sample Submission Minimum Sample Requirements EagleTrax App Features Stability Study Questionnaire Hazardous Drug Compounding Survey Customer Satisfaction Survey USP Published Revisions – What Changed?
|Microbiology Testing||Turnaround Time†|
|ScanRDI® Sterility Test||2 business days|
|ScanRDI® Method Suitability Test (required on file)||5 business days|
|BacT/Alert Sterility Test||8-10 calendar days|
|BacT/Alert Method Suitability Test (required on file)||8-10 calendar days|
|USP <71> Sterility Test||14-18 calendar days|
|USP <71> Sterility Test (daily read)||14-18 calendar days|
|USP <71> Sterility Test (direct inoculation)||14-18 calendar days|
|USP <71> Method Suitability Test (required on file)||7 business days|
|USP <85> Bacterial Endotoxin Test (turbidimetric)||2 business days|
|USP <85> Bacterial Endotoxin Method Validation (required on file)||7 business days|
|Endotoxin Oven Validation‡||5 business days|
|USP <60> Burkholderia Cepacia Complex (Bcc)||5 business days|
|USP <60> Burkholderia Method Suitability (required on file)||5 business days|
|USP <51> Antimicrobial Effectiveness (AME) Testing||35 calendar days|
|USP <51> Method Suitability Test (required on file)||14 calendar days|
|USP <61> Microbial Enumeration Test||7 business days|
|USP <61> Method Suitability Test (required on file)||7 business days|
|USP <62> Tests for Specified (Objectionable) Microorganisms||7 business days|
|USP <62> Method Suitability Test (required on file)||7 business days|
|USP <788> or USP <789> Particulate Count Test||3 business days|
|USP <790> Visible Particulates||1 business day|
|USP <922> Water Activity||3 business days|
|USP <1207> Container-Closure Integrity Test: Pressure Decay||3 business days|
|USP <1207> Container-Closure Integrity Test: Dye Ingress||5 business days|
|USP <1231> Water for Pharmaceutical Purposes||4 business days|
|USP <55> Biological Indicator (spore count)||10 business days|
|Biological Indicator (spore strips/ampoules/dry ampoules)||10 business days|
|Bioburden||7 business days|
|Growth Promotion Testing||7 business days|
|Incubation||7 business days|
|Plate Enumeration||2 business days|
|Incubation and Evaluation of Media-Filled Units||18 business days|
|Microbial Identification (subculture isolation and gram staining)||10 business days|
|Subculture||5 business days|
|Gram Staining||2 business days|
|ELISA Testing||5 business days|
† Beginning one (1) business day after the sample is received.
‡ At least one (1) control vial must be provided.
|Chemistry Testing†||Turnaround Time‡|
|Aqueous Solutions||1-3 actives||4 business days|
|4+ actives||7 business days|
|Non-Solutions×||1-3 actives||5 business days|
|4+ actives||7 business days|
|HCG||7 business days|
|USP <1730> Plasma Spectrochemistry ICP-OES (calcium, copper, magnesium, manganese, selenium, zinc)||5 business days|
|T3/T4||5 business days|
|Other Chemistry Testing|
|Appearance||2 business days|
|pH||2 business days|
|Raw Material Identification||5 business days|
|Raw Material Assay||2 business days|
|Density||2 business days|
|Specific Gravity||5 business days|
|USP <233> Elemental Impurities||5 business days|
|USP <281> Residue on Ignition||5 business days|
|USP <643> Total Organic Carbon (TOC)||10 business days|
|USP <645> Water Conductivity||10 business days|
|USP <731> Loss on Drying||5 business days|
|USP <741> Melting Range or Temperature||5 business days|
|USP <781> Optical Rotation||5 business days|
|USP <785> Osmolality & Osmolarity||5 business days|
|USP <905> Uniformity of Dosage Units||5 business days|
|USP <911> Viscosity-Capillary Method||2 business days|
|USP <912> Viscosity-Rotational Method||2 business days|
|USP <921> Water Determination||5 business days|
|Environmental Swab Testing||5 business days|
† Delays in analysis and/or additional costs may occur if the formula worksheet is not submitted, or if Eagle does not have current, developed protocols for the active ingredient(s) present in the sample.
‡ Beginning one (1) business day after the sample is received.
× Capsules, gels, suspensions, creams, animal treats, powder aliquots, suppositories, troches, tablets, etc.
|USP/NF Monograph Testing|
|Stability Indicating Method Development (4-6 weeks)|
|Stability Indicating Method Validation (4-6 weeks)|
|Stability Indicating Method Verification (1-2 weeks)|
|Stability Studies (Stability Study Questionnaire)|
|Stability Indicating Method Validation Report|
|Stability Indicating Method Verification Report|
|Stability Sample Storage|
|Final Stability Report|
|Final Stability Report (503B)|
|Tryptic Soy Agar (TSA) with Lecithin and Tween 80
(10 plates per pack)
||90 mm diameter||$27.50/pack|
|Tryptic Soy Agar (TSA) with Lecithin and Tween 80
(10 plates per pack)
||65 mm diameter||$27.50/pack|
|SurfaceShield Wipe Sampling and Cleaning Verification Kit||†1 Kit||†$60.00/kit|
† Reference SurfaceShield Wipe Sampling and Cleaning Verification Kit product page for alternative kit options and pricing.
View Minimum Sample Requirements
Pricing Request Form
USP <51> Antimicrobial Effectiveness:
Sterile articles packaged in multi-dose containers must be free of microorganisms throughout their entire shelf-life. Due to the potential for the introduction of microorganisms through the repeated withdrawal of individual doses, sterile products that are packaged in multi-dose containers should contain an antimicrobial preservative. However, the concentration of an added antimicrobial preservative can be kept to a minimum if the ingredients of the compounded formulation possess an intrinsic antimicrobial activity. Antimicrobial effectiveness, whether inherent in the product or as a result of an antimicrobial preservative, must be demonstrated through USP <51> antimicrobial effectiveness testing.
USP <61> Microbial Enumeration Test:
As the presence of microorganisms in nonsterile preparations has the potential to reduce and/or inactivate therapeutic activity and adversely affect the health of patients, compounders are required to ensure that nonsterile preparations have a low bioburden that complies with established specifications for microbiological quality as outlined in USP <61>. USP <61> Microbial Enumeration tests provide a quantitative evaluation of a product’s microbial content to demonstrate compliance with established specifications.
USP <62> Tests for Specific Microorganisms:
Table 1 in USP <1111> sets acceptance criteria for the presence of certain microorganisms in a nonsterile preparation based on its route of administration. The presence of these objectionable pathogens and microorganisms cannot exceed the acceptance criteria outlined in Table 1. USP <62> testing is designed to demonstrate compliance with these requirements by quantifying the presence of specified microorganisms.
USP <71> Sterility Testing:
USP <71> outlines the compendial requirements for sterility testing that must be followed in order to be able to claim that the results of the test provide evidence that the product is sterile.
USP <71> Method Suitability Testing:
USP <71> Method Suitability Testing (MST) must be performed prior to being able to claim that the results of a USP <71> sterility test provide evidence of a preparation’s sterility. Method Suitability Testing only needs to be completed once for each compounded formulation, and consists of two parts: i) a suitability test that confirms that the growth media used for sterility testing supports the growth of certain microorganisms and ii) a validation test that demonstrates that no components of the compounded preparation inhibit microbial growth.
USP <85> Bacterial Endotoxin Testing:
As bacterial endotoxins can pose health and safety hazards to patients, USP <85> requires bacterial endotoxin testing to detect and quantify the presence of endotoxins from Gram-negative bacteria in sterile compounds. To assure patient safety, the quantity of bacterial endotoxins may not exceed threshold limits defined in USP <85>. For each bacterial endotoxin test, inhibition validation testing is performed. This testing confirms that there are no components of the formulation that will interfere with the bacterial endotoxin test and that the testing used is sensitive enough to provide meaningful, accurate data.
USP <85> Endotoxin Oven Validation Testing:
Endotoxin Oven Validation determines depyrogenation cycle effectiveness by detecting and quantifying the presence of endotoxins from Endotoxin Control Vials (ECVs). By using ECVs placed in different locations within the oven to mimic load configurations, the validation determines if the depyrogenation cycle parameters are effective at removing or inactivating the pyrogen. Endotoxin Oven Validation should be performed at a minimum yearly, ensuring proper function of the oven.
USP <788> or USP <789> Particulate Count:
Solutions must be essentially free from observable particulate matter. Due to the small amount of material and the heterogenous composition that particulate matter represents, it cannot be quantitated by chemical analysis alone.
USP <1207> Container-Closure Integrity Testing:
USP <1207> container-closure integrity testing demonstrates the ability of the container-closure system to maintain the integrity of its microbial barrier throughout the entire shelf-life of a product. Eagle utilizes a pressure decay to test container-closure integrity, which is one of the deterministic methods recommended by USP <1207>. As sterility is an event-related occurrence, container-closure integrity testing is performed to support the claim that the sterile containers in which the preparation is packaged are capable of maintaining the sterility of the product throughout its shelf life.
USP <197> Spectroscopic Identification Tests:
Identification by IR USP <197>: This test provides conclusive evidence of the identity of a substance using infrared absorption spectrums compared to a USP reference standard. Conformance with both IR absorption and UV absorption test specifications, as called for in a large proportion of compendial monographs, leaves little doubt, if any, regarding the identity of the specimen under examination.
Identification by UV USP <197>: This test provides the identity of a substance using ultraviolet absorption spectrums compared to a USP reference standard. Conformance with both IR absorption and UV absorption test specifications, as called for in a large proportion of compendial monographs, leaves little doubt, if any, regarding the identity of the specimen under examination.
USP <643> Total Organic Carbon:
Total Organic Carbon (TOC) is an indirect measure of organic molecules present in pharmaceutical waters measured as carbon. Organic molecules are introduced into the water from the source water, purification and distribution system materials, biofilm growing in the system, and the packaging of sterile and nonsterile waters. TOC can also be used as a process control attribute to monitor the performance of unit operations comprising the purification and distribution system.
USP <621> Chromatography:
USP <621> Chromatographic separation techniques are multistage separation methods in which the components of a sample are distributed between two phases, of which one is stationary and the other is mobile. The analytical chromatography methods Eagle utilizes are designed to determine the concentration of the active ingredient(s) in a compounded preparation. Testing protocols are developed based on guidelines delineated in USP <621> Chromatography 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.