USP <621>ISO/IEC 17025FDA-RegisteredUSP-Compliant
Potency & Impurity
● 487 batches tested · Q4 2025
HPLC and LC-MS quantification of active pharmaceutical ingredients and related substances to ICH Q3B reporting thresholds.
| Parameter | Method | Specification / Range | Turnaround |
|---|---|---|---|
| Assay (API Content) | HPLC · USP <621> | 98.0–102.0% | 3–4 days |
| Related Substances | HPLC Gradient · ICH Q3B | NMT 0.15% each | 4–5 days |
| Dissolution (Single-Point) | USP Apparatus II · <711> | Q = 80% @ 30 min | 3 days |
| Content Uniformity | HPLC · USP <905> | AV ≤ 15.0 | 4 days |
| Residual Solvents | GC Headspace · ICH Q3C | Class 2: ≤ 410 ppm | 5 days |
| Organic Impurities | LC-MS/MS · ICH Q3B | ID threshold 0.10% | 5–7 days |
Instrument Inventory
- Agilent 1290 Infinity II UHPLC
- Waters Acquity UPLC-PDA
- Thermo Orbitrap Exploris LC-MS
- Agilent 7820A GC-FID/ECD
Column Qualification
System suitability per USP <621> run on every sequence. RSD ≤ 1.0% for replicate injections.
USP <711>ISO/IEC 17025USP <711>USP <1092>
Dissolution Testing
● 312 batches tested · Q4 2025
USP Apparatus I and II dissolution profiling for immediate release, extended release, and enteric-coated dosage forms with real-time fiber optic detection.
| Parameter | Method | Specification / Range | Turnaround |
|---|---|---|---|
| Immediate Release (IR) | USP App. II · Paddle · <711> | Q ≥ 80% @ 30–45 min | 3 days |
| Extended Release (ER) | USP App. I · Basket · <711> | Multi-point profile 1–24h | 4–5 days |
| Enteric Coated | USP App. II · Acid Stage 2h | NMT 10% @ 2h; Q ≥ 80% @ 45 min pH 6.8 | 4 days |
| Dissolution Profile (f2) | USP <1092> Comparative | f2 ≥ 50 (similarity factor) | 5 days |
| Intrinsic Dissolution | Wood Apparatus · USP <1087> | mg/min/cm² per monograph | 5–6 days |
| Capsule / Softgel | USP App. II + sinker · <711> | Per product specification | 3–4 days |
Apparatus Inventory
- Agilent 708-DS Dissolution Apparatus (8-vessel)
- Sotax AT7 Smart Dissolution System
- Distek 2500E Fiber Optic Real-Time
- Hanson SR8-Plus Dissolution Workstation
Calibration Standard
Prednisone tablet calibrators run quarterly per USP <711> Apparatus Suitability Test.
ICH Q1A(R2)ICH Q1AICH Q1B21 CFR Part 11
ICH Stability Studies
● 198 protocols active · Q4 2025
Long-term, accelerated, and intermediate stability programs for ANDA, NDA, and MAA submissions. Chambers continuously monitored with 21 CFR Part 11-compliant data loggers.
| Parameter | Method | Specification / Range | Turnaround |
|---|---|---|---|
| Long-Term (25°C/60% RH) | ICH Q1A(R2) · Zone II | 12 / 18 / 24 / 36 mo | Per protocol |
| Accelerated (40°C/75% RH) | ICH Q1A(R2) · Zone II | 3, 6 months | 3–6 months |
| Intermediate (30°C/65% RH) | ICH Q1A(R2) · Zone II/III | 6, 12 months | Per protocol |
| Photostability | ICH Q1B · Option 2 | 1.2M lux·h / 200 W·h/m² | 14–21 days |
| Freeze-Thaw Cycling | ICH Q5C · Biologics | 5 cycles · −20°C to +25°C | 10 days |
| In-Use Stability | ICH Q1A · Opened Container | Per product label claim | Per protocol |
Chamber Inventory
- 6× Binder KBF-720 Stability Chambers
- Thermotron S-Series Walk-In Room (Zone III/IV)
- Caron 6010 Photostability Cabinet (ICH Q1B)
- VWR −80°C Ultra-Low Freezer Array
Monitoring System
Dickson DicksonOne 24/7 IoT monitoring. Out-of-tolerance alerts within 15 minutes. Full audit trail retained 10 years.
USP <61> / <71>ISO/IEC 17025USP <71>FDA Sterility
Microbial & Sterility
● 221 batches tested · Q4 2025
TAMC/TYMC enumeration, specified organism detection, USP sterility testing, and bacterial endotoxins by kinetic LAL. Dedicated ISO 5 isolators for parenteral testing.
| Parameter | Method | Specification / Range | Turnaround |
|---|---|---|---|
| Total Aerobic Microbial Count | USP <61> · TAMC | NMT 10² CFU/g (oral) | 5–7 days |
| Total Yeast & Mold Count | USP <61> · TYMC | NMT 10¹ CFU/g (oral) | 5–7 days |
| Specified Organisms | USP <62> | Absent in 1g or 10 mL | 7 days |
| Sterility Testing | USP <71> · Direct Inoculation | No growth at 14 days | 14 days |
| Bacterial Endotoxins (LAL) | USP <85> · Kinetic Turbidimetric | Per route of administration | 2–3 days |
| Antimicrobial Effectiveness | USP <51> · Category 1–4 | Log reduction per category | 28 days |
Containment Capabilities
- Class 100 (ISO 5) Laminar Flow Isolators
- BioMérieux VITEK 2 ID/AST System
- Charles River Endosafe PTS LAL Reader
- Negative-pressure sterility testing suites
USP <231> / ICH Q3DISO/IEC 17025ICH Q3DUSP <232>
Raw Material Testing
● 629 materials tested · Q4 2025
Identity, purity, and elemental impurity testing for APIs and excipients. ICP-MS for heavy metals per ICH Q3D, FTIR identity confirmation, and full compendial release panels.
| Parameter | Method | Specification / Range | Turnaround |
|---|---|---|---|
| Identity (IR/Raman) | USP <197> · FTIR/FT-Raman | Conforms to reference spectrum | 1–2 days |
| Heavy Metals (ICP-MS) | USP <232> / ICH Q3D | Cd <0.5 µg/g; Pb <0.5 µg/g | 3–4 days |
| Loss on Drying | USP <731> · Gravimetric | Per compendial monograph | 1–2 days |
| Particle Size Distribution | USP <429> · Laser Diffraction | D10/D50/D90 per spec | 2 days |
| Water Content (KF) | USP <921> · Volumetric/Coulometric | NMT per specification | 1–2 days |
| Elemental Impurities | ICH Q3D · ICP-OES | Daily oral: Pb 5 µg/day | 4–5 days |
ICH Q2(R2)FDA-RegisteredEMA-CompliantPMDA-Ready
Regulatory & Validation
● 340+ ANDA packages supported
Method validation packages, OOS investigation reports, and FDA 483 CAPA documentation. Our regulatory scientists have supported 340+ ANDA submissions.
| Parameter | Method | Specification / Range | Turnaround |
|---|---|---|---|
| Method Validation | ICH Q2(R2) · Analytical Procedure | Specificity, Linearity, Accuracy, Precision | 4–6 weeks |
| Method Transfer | USP <1224> · Comparative | Equivalence criteria per protocol | 2–4 weeks |
| OOS Investigation | FDA OOS Guidance 2006 | Phase I/II investigation report | 5 business days |
| Cleaning Validation | FDA 21 CFR 211.67 · HBEL | MACO / visual inspection | 2–3 weeks |
| Audit Support (FDA 483) | CAPA Documentation Package | Root cause + corrective action | 10 business days |
| Stability Protocol Design | ICH Q1A / Q1D Bracketing | Protocol + SAP + data review | 1–2 weeks |