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 Laboratory Testing Services, Turnaround Times, and Pricing

 

We offer the highest quality in science-based microbiological and chemistry testing.  Our state-of-the-art equipment, combined with the experience and knowledge of our team, makes EAGLE the best choice for all your testing 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) 7 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
Potency Testing  
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
Additional Information  
       RUSH Service is available for double the regular test price.
       SUPER RUSH Service is available for triple the regular test price.  Call for details.
       A $100 cancellation fee will be assessed if cancellation is requested after the sample(s) have arrived at our facility.
If testing has been initiated, the full price of the test will be assessed.
       All pricing is subject to change at any time.

 

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.

 

Please contact our Client Care for the most up-to-date information on our testing services and for assistance with submitting a sample via EagleTrax. 

 

Additional Services
Validation Services
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)
Miscellaneous Fees
Stability Indicating Method Validation/Verification Report
Stability Sample Storage
Administrative Fee
Final Stability Report
Final Stability Report (503B)
Reference Standard(s)

 

We look forward to serving you.

View Minimum Sample Requirements

 

Pricing Request Form

Please complete the form below to receive pricing.

 

Testing Defined

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. 

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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.

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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.

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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. 

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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.

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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.

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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.

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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.

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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. 

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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.

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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.

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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.

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