CEE 2 - Pharmaceutical Analysis II (AI generated)

Flashcards cover key definitions, QC differences, analytical validation parameters, RMQC/IPQC/FPQC tests, container & stability studies, ensuring comprehensive exam review of the lecture.

What is the definition of a medical product?

Any substance or combination of substances presented for treating or preventing disease, or administered to restore, correct, or modify physiological functions or for diagnosis.

What two main components make up a medical product?

Active Pharmaceutical Ingredient (API) + Excipient(s).

Define formulation in pharmaceutical science.

The process of combining API and excipients to produce a stable, patient-acceptable final medical product with good bioavailability.

State the four basic medication needs that constitute pharmaceutical care.

Medication is appropriate, safe, effective, and the patient is adherent/compliant.

Differentiate Quality Assurance (QA) from Quality Control (QC).

QA is process-based, ensuring policies/SOPs are followed and conducting audits, while QC is product-based, testing raw, in-process, and finished materials to verify they meet specifications.

What does GMP stand for and what is its focus?

Good Manufacturing Practice; it covers all aspects that influence product quality, ensuring consistency and control of manufacturing processes.

List the four major Quality Control stages in manufacturing.

Raw Materials QC (RMQC), In-Process QC (IPQC), Finished Product QC (FPQC), Packaging QC.

Give the purpose of a Certificate of Analysis (CoA).

To document that a material conforms to approved technical standards and specifications.

Name the four key attributes described in a pharmacopoeial monograph.

Identity, Strength/Potency, Purity, Performance.

Define accuracy in analytical validation.

Closeness of test results to the true value.

Define precision in analytical validation.

Degree of agreement among individual results when the method is applied repeatedly.

What is robustness in method validation?

The capacity of an analytical method to remain unaffected by deliberate variations in parameters.

Explain specificity in analytical methods.

The ability to assess the analyte unequivocally in the presence of components such as impurities, degradants, or matrix.

What does sensitivity refer to in analytical chemistry?

The ability of a method to discriminate between small differences in analyte concentration.

Define linearity in method validation.

The ability of the method to obtain results that are directly proportional to the concentration of analyte within a given range.

Differentiate qualitative from quantitative pharmaceutical analysis.

Qualitative reveals the identity or presence/absence of components; quantitative indicates the exact amount of each substance present (also called assay).

Give two physical identity tests for raw materials.

Specific gravity (using a pycnometer) and refractive index (controlled wavelength & temperature).

Which instrument is used to measure optical activity?

Polarimeter.

Name two instrumental techniques used for raw-material identification.

Infrared (IR) Spectroscopy and High-Performance Liquid Chromatography (HPLC).

What are the two main microbial assay methods for antibiotics?

Cylinder-plate method and Turbidimetric (tube) method.

List three common adulteration types detected during RMQC.

Sophistication, Substitution, Admixture (also Spoilage & Deterioration).

State the acceptable primary and final moisture ranges for granules in IPQC.

Primary: 31–35 %; Final: 0.55–1 %.

What test measures powder flow via the angle made by a powder cone?

Angle of Repose.

Give the interpretation for an Angle of Repose < 25°.

Excellent flowability.

Define Hausner’s ratio and its formula.

Bulk flow index = initial volume ÷ tapped volume; assesses powder’s ability to settle.

What Carr’s Compressibility Index range indicates excellent flow?

5 – 13 %.

Which equipment is standard for tablet friability testing?

Roche Friabilator (25 RPM for 4 min).

State the friability acceptance limit for conventional tablets.

Not more than (NMT) 1 % weight loss; new formulations NMT 0.8 %.

Describe the disintegration acceptance for uncoated tablets.

Complete disintegration in distilled water within 30 minutes.

What is ‘Q’ in dissolution testing?

The tolerance: percentage of drug dissolved specified in the monograph label claim (LC).

Identify Apparatus I and II for dissolution tests.

Apparatus I – Basket; Apparatus II – Paddle.

List four key FPQC tests for capsules.

Identification, Assay (content uniformity), Disintegration, Dissolution (plus dosage-unit uniformity).

Name two media used in microbial limit tests for non-sterile products and what they detect.

Tryptone Soy Agar – total aerobic count; Potato Dextrose Agar – total yeast and molds.

What is sedimentation volume (F) in suspensions?

Ratio of ultimate sediment volume to the original volume before settling; ideal F ≈ 1.

Which dye is used in Leaker’s test for ampoules?

1 % methylene blue solution.

Give the two BET/LAL positive-result indicators.

Formation of a firm gel (gel-clot) at the tube bottom; or turbidimetric/photometric signal exceeding control limit.

State the particle limits for injections > 100 mL by Light Obstruction (Method I).

NMT 25 particles ≥ 10 µm/mL and NMT 3 particles ≥ 25 µm/mL.

Summarize the rabbit pyrogen test dose and temp recording interval.

Inject 10 mL/kg IV into ear vein (3 rabbits); record temperatures every 30 min for 1–3 hours.

Define leaching and sorption in container interactions.

Leaching – container components migrate into drug; Sorption – drug adsorbs/absorbs into container.

List the four general container classes.

Well-closed, Tight, Hermetic, Light-resistant.

Which glass type is highly resistant borosilicate suitable for all products?

Type I glass.

What new QC test differentiates Type I glass from Types II & III by alkali content?

Glass Grain Test.

State the light-transmission limit for colored glass (non-parenteral) between 290–450 nm.

Not more than 10 % at any wavelength within the range.

Give two examples of plastic types and typical use.

PET – beverage bottles; PVC – blister packs and medical tubing.

What IR range is scanned for identifying polyethylene containers?

3500–600 cm⁻¹.

State the heavy-metal limit in physicochemical tests for plastics.

Not more than 1 ppm.

Which three biological reactivity tests classify plastics (USP Class I–VI)?

Systemic Injection, Intracutaneous, Implantation tests.

Define stability study ‘expiration date’.

Time at which API content falls to 90 % of label when stored under recommended conditions (expiration = manufacture + shelf-life).

List the five areas in which a drug must remain stable.

Physical, Chemical, Microbiological/Sterility, Toxicity, Therapeutic Effect.

Match ICH Stability Zone III with its long-term test conditions.

30 °C ± 2 °C / 35 % RH ± 5 % for 12 months.

What are accelerated stability conditions for ambient products?

40 °C ± 2 °C / 75 % RH ± 5 % for 6 months.

Explain how RMQC, IPQC, and FPQC support Quality by Design (QbD).

They provide data-driven controls at raw-material, process, and final-product stages, enabling understanding of variability and ensuring predetermined quality throughout development rather than end-product testing alone.