Testing Types
USP Compendial Monograph Testing

USP Compendial Monograph Testing

Compendial testing performed in accordance with USP monograph requirements to support product quality, regulatory compliance, batch release, and lifecycle quality programs.

Terms and Conditions

I. Confidentiality:

PLS Analytical ("PLSA") maintains strict confidentiality with its clients.

Formal Confidentiality agreements may be initiated by the client or by PLS Analytical.

II. Financial Information

Payment in advance is required for clients whose credit has not been established with PLSA.
Payment terms are “NET 15 days from receipt of the results”. Buyer agrees to pay all costs, including, but not limited to attorney and accounting fees and other expenses of collection resulting from any default by buyer in any of the terms of this contract.
Purchase orders or valid credit card information are REQUIRED. Orders submitted without this information may cause delays in testing.
For third party billing a signed purchase order must be received from the party paying for the service.
A surcharge of 50% or greater will be added for EXPRESS service. Express is subject to prior approval and availability.
Pricing is designed for single samples. Project discounts may be available. Quotations will be provided free of charge.
A minimum billing of $25.00 will be charged on all samples including those samples cancelled at the customer's request.
Clients that request Raw Data will have a copy sent to them electronically (at no charge) along with their report. There may be a surcharge for copies of the raw data and report when requested after initial sending is completed.
Additional charges may be assessed (e.g. hazardous samples, composite fee).
Shipping costs will be charged to clients that would like containers, coolers or ice packs returned.
Liability of PLSA is limited to an amount no greater than the amount invoiced.

III. Sample Submission:

Fill out the Sample Submission Form COMPLETELY, including product name, lot number, test, methods, and the amount of samples sent. Incomplete information may cause a delay in providing services.
All results will be reported by the method supplied and/or identified. If a limit is not supplied, we will default to associated compendia limits, or “Report Results” when compendial limits are not available.
All samples should be labelled with company name, product name and lot number. Samples received without a lot number will be sent back to the client for proper labeling. Hazardous Substances must be appropriately labeled for the protection of office and laboratory personnel.
- Shipping carton exterior must be labeled as to the hazard enclosed; caustic, cytotoxic, antineoplastic, explosive, corrosive, toxic, or carcinogenic, etc.
- Safety Data Sheet (SDS) must be provided for all Hazardous samples.
- Additional charges may be applied.
- Please place Sample Submission Form, SDS and any other correspondence submitted, in an envelope and place at the top of the box or affixed to the outside of the box. Failure to use the PLSA Submission Form for Analytical Services may delay results.

IV. Retention and Disposal:

Samples are retained for a period of 30 days after completion of analysis.
Special PRIOR arrangements must be made to return or retain samples under other conditions.
Unless alternate arrangements have been made, raw data will be retained for 6 years after final report date.

IMPORTANT

Turnaround Times:
- In calculating turnaround times, pending all appropriate documentation is in order; if the sample is received before 10 am then the day the sample is received is Day 1 otherwise it will be on the next business day.
- Standard TAT is 10 Business days.
- Express Service is subject to prior approval, availability and surcharges.
- For International orders, please allow sufficient time for samples to clear customs.
Please pack samples appropriately to prevent breakage.
Because transportation of materials to our facilities can have significant impact on the moisture content of client sample materials, PLS Analytical will not accept client-provided Loss on Drying/Moisture content results. When required for testing, the Loss on Drying/Moisture Content will be performed at PLS Analytical and will be billed to clients at a flat rate. Please contact our Customer Service Team for current associated costs.
If growth is obtained during microbial enrichment testing, a gram stain will be performed and billed to the client. Please contact our Customer Service Team for current associated costs.
For Questions regarding the above information please contact our Client Services Department at 732-698-5050.

I confirm that I have read and accept the terms and conditions.

Sample Submission Form

Submitter Information

Date

Company Name / Address

Contact Name

Billing

Send Invoice To

If differentSame as Report

Name and email for invoicing

Order References

PO Number*

Quote Number*

Turn Around Time

StandardRush

Express, needed byInclude Raw Data

Controlled substance

Yes No

Microbiology sample suitability

YesNo

Analytical sample: method verification required

YesNo

Special Instructions

Fill The Sample Columns

SAMPLE NAME	LOT # (ONE LOT PER LINE)	METHOD (MUST BE PROVIDED)	TEST REQUESTED (MUST BE PROVIDED)	SPECIFICATION (MUST BE PROVIDED)	QUANTITY

Required for Testing to Begin Customer Initials and Date

Overview

What are USP Compendial Monographs?

USP Compendial Monographs define official quality standards for pharmaceutical ingredients, finished drug products, excipients, dietary supplements, and other healthcare materials. At PLS Analytical, these monographs guide the evaluation of identity, strength, purity, performance, and other critical quality attributes to support compliance with recognized pharmacopeial requirements.

What is USP Compendial Monograph Testing?

PLS Analytical performs USP compendial monograph testing using official USP methods and acceptance criteria to verify product quality and compliance. Depending on the applicable monograph, studies may include identification, assay, impurity evaluation, dissolution, content uniformity, microbial testing, physical characterization, and other product-specific requirements. Testing supports raw materials, APIs, excipients, in-process materials, finished products, stability studies, and commercial release programs.

Why it Matters

Meeting USP monograph requirements is essential for demonstrating product quality, supporting regulatory compliance, and maintaining consistency throughout the pharmaceutical lifecycle. Compendial testing helps manufacturers verify that products meet established quality standards while reducing the risk of batch rejection, regulatory observations, and supply chain disruptions.

PLS Analytical delivers scientifically rigorous compendial testing aligned with USP standards, helping manufacturers generate reliable, submission-ready data that supports quality systems, regulatory inspections, commercial manufacturing, and global market requirements.

Testing Services

Execute USP monograph requirements with confidence

PLS Analytical performs USP compendial monograph testing to support product development, raw material qualification, release testing, stability programs, and regulatory compliance activities across pharmaceutical and healthcare products.

1. Raw Material (Excipients & API) Compendial Testing

Raw material compendial testing evaluates active pharmaceutical ingredients and excipients against applicable USP monograph requirements. Scientifically robust data supports API qualification, excipient testing, incoming material release, and pharmacopeial compliance.

2. Finished Product Compendial Testing

Finished product compendial testing evaluates pharmaceutical products against USP monograph specifications and acceptance criteria. Scientifically robust data supports commercial batch release, product qualification, quality control programs, and regulatory compliance.

3. Stability & Lifecycle Compendial Testing

Stability and lifecycle compendial testing evaluates product quality throughout defined stability programs using applicable USP monograph methods. Scientifically robust data supports stability programs, shelf-life determination, lifecycle management, and regulatory submissions.

Advantages

Built for reliable, compendial-compliant results

USP compendial testing provides standardized quality data that supports product release, regulatory compliance, and lifecycle quality management.

Standardized Quality Assessment

Testing is performed according to recognized pharmacopeial procedures, ensuring consistency and comparability across products, facilities, and quality programs.

Reliable Release Decisions

Compendial testing generates objective quality data that supports batch release, material qualification, and routine quality control activities.

Reduced Regulatory Risk

Demonstrating compliance with official USP standards helps strengthen inspection readiness, support regulatory submissions, and reduce compliance-related observations.

Regulatory Compliance

USP compendial monograph testing supports compliance with recognized pharmacopeial standards referenced throughout pharmaceutical quality systems and regulatory frameworks. Testing documentation can support product registration activities, audits, inspections, release programs, and ongoing quality management.

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