Laboratory & Analytical Instrument Centre

22 specialist instruments across seven testing categories — HPLC chromatography, atomic absorption spectroscopy, UV-Vis spectroscopy, microbiology, physical-chemical analysis, microscopy, and stability — supporting full-chain quality control from incoming raw material to finished goods release.

22

Instruments on site

9

Dedicated laboratory rooms

7

Testing categories

GMP

Good Manufacturing Practice certified

2 units

4 units

3 units

1 unit

5 units

2 units

GMP

Certified facility · Lushi

CoA

Issued for every batch

HPLC/UV Tested

Strict pharmacopoeia compliance

24 Mo

Retained batch samples

R&D Team

PhD-led formulation support

22 specialist instruments. Seven testing categories.

All instruments are subject to periodic calibration with maintained instrument records. Core analytical instruments (HPLC, atomic absorption, UV-Vis) undergo system suitability testing before each use. All measurement data is traceable to original records.

HPLC System

High Performance Liquid Chromatograph · Model P1010 · Ref. JY001

Flow Range

0.001–9.999 ml/min

Flow Accuracy

±0.5%

Repeatability

RSD ≤ 0.1%

Max. Pressure

≤ 42 MPa (316L)

Atomic Absorption Spectrometer

Atomic Absorption Spectrometer · ZCA-1000SFB · Ref. JY002

Wavelength Range

185–910 nm

Spectral Bandwidth

0.1/0.2/0.4/1.0/2.0 nm

Wavelength Accuracy

±0.1 nm

Baseline Drift

0.002A/30min

Vertical Laminar Flow Cabinet

Vertical Laminar Flow Cabinet · SW-CJ-1D · Ref. JY003

Cleanliness Class

Class 100 @ ≥0.5 μm (US Fed 209E)

Noise Level

≤ 62 dB(A)

Airflow Velocity

0.3–0.45 m/s

Power Supply

AC 220V 130W

Vertical Laminar Flow Cabinet

Vertical Laminar Flow Cabinet · SW-CJ-1D · Ref. JY004

Cleanliness Class

Class 100 @ ≥0.5 μm (US Fed 209E)

Particle Count

≤3.5 particles/L (Class 100)

Airflow Velocity

0.3–0.45 m/s

Power Supply

AC 220V 130W

UV-Vis Spectrophotometer

UV-Vis Spectrophotometer · 1800PC · Ref. JY005

Wavelength Range

190–1100 nm

Wavelength Accuracy

±0.4 nm

Slit Width

2 nm

Display

TFT colour LCD, 65,536 colours

Analytical Balance (0.01 mg)

Analytical Balance · AUW120D · Ref. JY006

Capacity

120 g (dual range)

Readability

0.01 mg (1/100,000 g)

Calibration

Automatic internal calibration

Origin

Imported — Japan

Constant Temperature Incubator

Constant Temperature Incubator · DH360 · Ref. JY007

Temperature Range

5–65°C

Temp. Accuracy

0.01 mg (1/100,000 g)

Colony Counter

Colony Counter · YLN-30 · Ref. JY008

Count Range

0–999

Power Supply

220V · 10W

Muffle Furnace

Muffle Furnace · SX2-2.5-10 · Ref. JY009

Rated Power

2.5 KW

Temp. Control Range

300–1000°C

Heat-Up Time

≤ 50 min (empty)

Hot Air Drying Oven

Hot Air Drying Oven · 101-0 · Ref. JY010

Temperature Range

RT+10 – 300°C

Temp. Accuracy

±1.0°C

Temp. Fluctuation

±1.0°C

Power

1.6 KW · 220V/50Hz

High-Speed Pulverizer

High-Speed Pulverizer · 150 g · Ref. JY011

Capacity

150 g

Rotation Speed

27,000 r/min

Mesh Range

70–300 mesh

Conductivity Meter

Conductivity Meter · DDS-11A · Ref. JY012

Measurement Range

0–1999 μS/cm

Basic Error

±1.5% f.s.

Electric Constant-Temp Water Bath

Constant Temperature Water Bath · HH-2 · Ref. JY013

Temperature Range

RT – 100°C

Temperature Fluctuation

≤ ±0.05°C

Temp. Accuracy

≤ ±1°C

pH Meter

pH Meter · PH-3C · Ref. JY014

pH Range

0.00–14.00 pH

Readability

Class 0.01 · ±0.01 pH

Temp. Compensation

0–60°C

Stability

±0.01 pH/3h

Portable Autoclave

Portable Autoclave · XFS-280A · Ref. JY015

Design Temp.

129°C

Design Pressure

0.17 MPa

Power

2 KW

Rotary Evaporator

Rotary Evaporator · RE-201D · Ref. JY016

Flask Volume

1 L

Collection Flask

1 L

Rotation Speed

120 r/min

Power Supply

220V / 50Hz

Digital Biological Microscope

Digital Biological Microscope · MX117 · Ref. JY017

Magnification

40–1600×

Camera

8.3 MP sensor

Interface

External digital camera

Software

Image analysis software package

Biological Safety Cabinet

Biological Safety Cabinet · 900AZ · Ref. JY018

Power

1100 W

Application

Sterile work environment protection

Stability Test Chamber

Stability Test Chamber · YWH-250Z · Ref. JY019

Power

1500 W

Application

Accelerated product stability testing

Microbial Limit Tester

Microbial Limit Tester · Ref. JY021

Application

Microbial limit testing

Location

Microbiology Lab

Triple-Function UV Analyzer

Triple-Function UV Analyzer · ZF-1 · Ref. JY022

Application

TLC fluorescence detection

Wavelengths

254 nm / 365 nm

Biochemical Incubator

Biochemical Incubator · SHP-160 · Ref. JY023

Power

1200 W

Application

Microbial culture

Moisture Analyzer

Moisture Analyzer · 10A · Ref. JY024

Application

Finished product moisture content

Location

General Instrument Room

9 dedicated laboratories, precisely zoned by function.

Each testing room is independently partitioned to prevent cross-contamination. Microbiology, sterile, and potency rooms are each equipped with laminar flow cabinets. High-temperature and physical-chemical rooms have independent exhaust systems, compliant with GMP clean zone management requirements.

HPLC Room

HPLC Laboratory

2 Instruments / workstations

Spectroscopy Suite

3 Instruments

Microbiology Lab

Microbiology Laboratory

3 Instruments

Physical-Chemical Lab

3 Instruments

General Instrument Room

4 Instruments

High-Temp Room

High Temperature Lab

2 Instruments

Microscopy Room

1 Instruments

Preparation Room

3 Instruments

Sterile & Potency Rooms

2 Instruments

Behind every certificate of analysis, a real specialist signed it.

We’re not a trading company. When you have a formulation question or a quality issue, you’re talking to the person who was in the lab. Every technical claim we make is backed by someone with direct production accountability.

Our QA and R&D team is composed of phytochemists, analytical chemists, and veterinary pharmacology specialists. If you have any question about a test report or specification, you speak directly with the expert responsible for that batch — not through a customer service intermediary.

Prof. Dr. Zhao Jinzhong

Chief Scientific Advisor

Over 20 years of expertise in medicinal chemistry and chemical biology. Lead researcher specializing in the discovery, extraction, and functional application of bioactive plant compounds. Has authored over 70 high-impact papers in leading international journals and holds multiple patents for natural product extraction technologies.

Prof. Dr. Zhang Yongpo

Senior R&D Scientist

Specializes in organic chemistry and the targeted extraction of natural active ingredients. Leads formulation methodology and coordination chemistry research to enhance the stability and bioavailability of botanical extracts. Published extensively in leading molecular structure and inorganic chemistry journals.

Prof. Dr. Zhang Yongpo

Senior R&D Scientist

Dr. Guo Dongdong

Extraction Process Engineer

Expert in green chemistry and advanced organic synthesis. Focuses on scaling up laboratory extraction parameters into highly efficient, sustainable industrial production lines, optimizing solvent routes and temperature controls to maximize active ingredient yields.

Full-chain testing. Batch release report on every lot.

From incoming raw herb to finished goods dispatch, 17 inspection checkpoints are established across the full process. All testing data is traceable to original instrument records. A batch release Certificate of Analysis (CoA) is provided with every shipment.

Potency Assay

Target active markers are precisely quantified by HPLC external standard method. Reference standard solutions are freshly prepared per batch. Data precision to 0.01%. UV-Vis spectrophotometry is used as a complementary quantification tool.

Primary marker HPLC quantification

HPLC · P1010

Total flavonoids / polysaccharides · UV

UV · 1800PC

TLC botanical identity

ZF-1 UV Analyzer

Heavy Metals Testing

Atomic absorption spectrometer (AAS) tests four heavy metals — lead, cadmium, arsenic, and mercury — with auto-adjusting wavelength from 185–910 nm. Results comply with EU and US pharmacopoeial limits. Reports included with every shipment.

Pb ≤ 5 ppm

AAS · ZCA-1000SFB

Cd ≤ 0.5 ppm

AAS · ZCA-1000SFB

As ≤ 2 ppm · Hg ≤ 0.1 ppm

AAS · ZCA-1000SFB

Microbiology Testing

Dedicated microbiology laboratory equipped with biosafety cabinet, colony counter, and laminar flow cabinet. Testing follows pharmacopoeial standards for TAMC, TYMC, and specified microorganism testing.

TAMC ≤ 10⁵ CFU/g

Colony Counter

TYMC ≤ 10³ CFU/g

Biological Safety Cabinet

E. coli / Salmonella · Specified organisms

Microbial Limit Tester

Physical-Chemical Testing

A Japanese-import Shimadzu 0.01 mg analytical balance ensures weighing precision. pH meter and conductivity meter are used for pH and solution conductivity testing. A moisture analyzer measures moisture content on finished extract powder.

Moisture content ≤ 5% · LOD method

Moisture Analyzer

pH measurement

PH-3C · ±0.01 precision

Precision weighing · 0.01 mg readability

Shimadzu AUW120D

Microscopic Identification

An 8.3 MP digital biological microscope (40–1600×) is used for tissue morphology identification and powder characterisation of botanical raw materials. High-resolution digital images are archived as part of the original batch record.

Powder / tissue microscopic ID

MX117 · 1600×

Digital archiving of cellular features

8.3 MP camera

Stability Testing

The stability test chamber (YWH-250Z) supports both ICH Q1A accelerated and long-term stability studies. Shelf-life data is established for every product, supporting client regulatory submissions and labelled shelf-life claims.

Accelerated stability · 40°C/75%RH

YWH-250Z

Long-term stability · 25°C/60%RH

ICH Q1A

Retained sample management per batch

System traceability

Every batch starts small — so your large order never fails

Before a single kilogram leaves our facility, every new specification or custom formulation is validated at lab scale first. We de-risk the process at milligrams, not at metric tonnes — and only scale up once purity, yield, and all QC parameters are confirmed.

Stage 01 · Lab

Laboratory Prototype

Your target specification is first reproduced at 50–200g scale using analytical-grade reagents. Extraction parameters, solvent ratios, and resin conditions are optimized until HPLC confirms the marker content.

Batch size

50 – 200 g

Duration

3 – 7 days

Output

Method SOP + CoA draft

Client deliverable

Free 20-100 g sample

Stage 02 · Pilot

Pilot Scale Validation

The lab SOP is transferred to pilot reactors (50–500 kg). Yield reproducibility, solvent recovery, and drying uniformity are validated across three consecutive batches before GMP production is authorized.

Batch size

50 – 500 kg

Batches required

3 consecutive

Validated

Yield · purity · CoA

Client deliverable

Pilot CoA + price lock

Stage 03 · GMP Production

Full-Scale GMP Batch

Validated SOP is locked into the GMP batch record. Production runs at tonne scale under real-time QC monitoring. Every released batch ships with a signed CoA matching the pilot specification exactly.

Batch size

1 – 20 MT per run

QC gate

In-process + final release

CoA signed by

QA Manager

Lead time from stock

5 – 7 business days

Our commitment to every customer: the specification you approve at lab stage is the specification that ships on every commercial batch — same marker content threshold, same analytical method, same test parameters. If a production batch falls below the agreed spec, it does not leave the warehouse and we re-run at no charge.

24-month retention program. Real stability data, not assumed shelf life.

We retain a physical sample of every production batch for 24 months and run structured stability studies against real storage conditions. Shelf life claims on our CoA are derived from measured data — not extrapolated from a manufacturer’s guideline or assumed from industry convention.

Program Overview

24 Mo

Retention period per production batch

6

Scheduled test points across the stability program

100%

Batch coverage — no sampling, no exceptions

Retained Sample Program — Batch Lifecycle

Day 0 · Batch Release

Retention sample drawn and sealed at production

At the point of batch QC release, a minimum 200g retention sample is drawn from the finished production lot, sealed under nitrogen in a triple-layer foil pouch, and logged into the retention system. The sample is stored under ICH-defined long-term stability conditions (25°C ± 2°C / 60% RH ± 5%) in a dedicated temperature-controlled retention room — separate from commercial inventory.

Months 3, 6, 12, 18 · Interim Testing

Scheduled stability test points — full panel

At predefined intervals (e.g., 3, 6, 12, 18, and 24 months), samples are pulled from the retention room for a full analytical panel. This allows us to track active compound degradation curves and ensure specification compliance over time.

Month 24 · Full Stability Report

Complete stability dossier issued and archived

At 24 months, a complete stability report is compiled covering all test points, trend analysis, and a formal assessment of shelf life confirmation. The report is archived permanently and is available to qualified buyers — pharmaceutical manufacturers and regulatory submission teams — on request under NDA. Shelf life declarations on our CoA reference this measured data, not assumed guidelines.

Ongoing · Dispute Resolution Reserve

Retained sample available for third-party arbitration

Throughout the 24-month retention period, the retained sample serves as the reference material for any incoming QC discrepancy reported by a buyer. If a batch fails your QC and you report it, our QA manager runs a re-test of the retained portion under the same test conditions. If third-party arbitration is escalated to SGS, Intertek, or Bureau Veritas, the retained sample is the submitted reference — providing an objective, documented baseline for every dispute.

Retained Sample Program — Batch Lifecycle

Primary Active Marker Quantification (HPLC/UV)

The core active compound is quantified at every time point using validated in-house methods. Any decline beyond the specification tolerance triggers an immediate QA investigation. This is the single most critical data point in the stability program.

Secondary Markers & Fingerprinting (TLC/HPLC)

For complex botanical extracts, secondary compounds and overall chromatographic fingerprints are tracked to ensure the full-spectrum profile remains stable during storage, ruling out uncharacteristic degradation.

Moisture Content & LOD

Moisture is the primary driver of active compound degradation and microbial risk. Routine Loss on Drying (LOD) analysis at each time point confirms that our sealed packaging maintains its strict moisture defense across the full 24-month period.

Appearance, Color, and Odor

Visual and olfactory assessment against the initial release standard. Color shifts, powder cohesion, and odor intensity are documented descriptively. Early-stage degradation is often detectable organoleptically before HPLC values shift significantly.

Physical Integrity & Solubility

Particle structure changes due to moisture uptake can impair flowability or reconstitution. We re-verify physical parameters—including dissolution rates for water-soluble grades—ensuring the material remains strictly fit-for-purpose for your manufacturing equipment.

Microbiology Profile (Selected Time Points)

Total plate count, yeasts, and molds are tested at critical time points. A product that passes release microbiology but fails at the 12-month test point indicates a latent packaging or storage condition failure — caught safely inside our facility.

Stability data available to qualified buyers

Pharmaceutical manufacturers and regulatory submission teams can request the full stability dossier — including all time-point data, trend charts, and the formal shelf life confirmation report — under a signed NDA. The data is real, not a summary.

Accelerated stability data on request

In addition to long-term conditions (25°C / 60% RH), we run accelerated stability studies at 40°C / 75% RH per ICH Q1A(R2) guidelines. Accelerated data allows buyers to estimate performance in challenging distribution environments and is available for pharmaceutical dossier submissions.

Shelf life is a measured conclusion, not an assumption

The 24-month shelf life declared on our CoA is the result of a completed stability program, not an industry default or a manufacturer’s estimate. When the data shows a product is stable beyond 24 months, we extend the claim. When it doesn’t, we say so.

Inside Our Analytical Lab.

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Lab-7

Lab-8

Tell us what
you need.
We'll take it from there.

Whether you need an in-stock grade, a custom specification, regulatory documentation, or a facility audit — the right person on our team will respond within one business day.

Request a Free 20-100g Sample

Any product. Any grade. Worldwide express dispatch within 48 hours.

Request a Bulk Pricing Quote

Get transparent, tier-based pricing for standard extracts or custom formulations. Includes CIF/FOB freight estimates. Fast response within 12 hours.

Submit a Custom Formulation Brief

New botanical, new grade, or compound formula — free feasibility assessment within 48 hours.

Schedule a Factory Audit or Technical Call

Speak directly with our commercial directors or arrange a virtual tour of our Lushi extraction facility. No scripts, just solutions.

All enquiries confidential · NDA available on request · No unsolicited follow-up · One business day response guaranteed

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We reply within 1 business day with pricing, lead time, and sample tracking number.

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