Lot COA · documents
COA by lot number.
Wholesale shipments carry the certificate of analysis of every lot in them. Enter a lot number from a carton or packing list and we send that lot's certificate; quoting a new order, ask for the COA of the lot allocated to it before you approve.
- A COA per lot in every shipment
- The allocated lot's COA with the quote, on request
- Specification sheet and SDS on request
01
Contents of a wholesale COA
Product and size, lot number, manufacture and expiry dates; then each release test with its method, acceptance criterion and the lot's result. Bacteriostatic water, 10 mL:
| Test | Method | Acceptance criterion |
|---|---|---|
| Appearance | Visual examination against the stated description | Clear, colorless solution |
| Water and benzyl-alcohol component identity | Qualified water-grade document review plus GC retention-time and FTIR comparison against a qualified benzyl-alcohol reference | Water grade conforms to the released specification and the preservative is identified as benzyl alcohol; component identity does not by itself establish concentration, sterility or finished-product status |
| Benzyl alcohol content | GC-FID with a qualified external reference and validated v/v calculation | 0.9% ± 0.1% (v/v) |
| pH | Potentiometry (USP <791>) | 5.0–7.0 |
| Elemental impurities | ICP-MS (USP <233>), closed-vessel microwave digestion | Cd NMT 0.2; Pb 0.5; As 1.0; Hg 0.3; Co 0.5; V 1.0; Ni 2.0; Li 5.0; Sb 1.0; Cu 5.0 ppm; sum of Cd, Pb, As, Hg, Co, V and Ni <4.0 ppm |
| Antimicrobial effectiveness | USP <51>, Category 1 challenge with five specified organisms through 28 days | Meets USP <51> Category 1 criteria for the tested released formulation; this result does not sterilize a contaminated vial or replace aseptic controls |
| Fill volume | Gravimetric determination with validated density correction | 10.00 mL/vial ±3.0% |
| Particulate matter | Light obscuration (USP <788> Method 1); visible particles per USP <790> | NMT 6000 particles ≥10 µm and NMT 600 particles ≥25 µm per container; essentially free from visible particulates |
| Bacterial endotoxins | Kinetic chromogenic LAL (USP <85>) | NMT 0.25 EU/mL |
| Sterility | USP <71>, membrane filtration with demonstrated method suitability | Sterile — no growth |
Before you accept a lot
- The lot on the COA is the lot on the carton packing list.
- Remaining shelf life meets your minimum — state it in the quote request.
- Benzyl alcohol inside 0.8–1.0% (v/v), pH inside 5.0–7.0.
- Sterility and endotoxin results are reported, not just “complies”.
02
Three ways to a lot COA
- Quoting a new order: ask for the COA in the quote request notes — our sales team sends the COA of the lot allocated to it before you approve.
- Shipment received: enter the lot number above; the certificate goes to you by e-mail or WhatsApp.
- Lot COAs are not published on the site; every shipment carries the COA of each lot in it.
03
Document questions
Why are lot COAs not on the site?
They are issued per lot and sent by our sales team — with the quote, with the shipment, or on request with the lot number.
Can the COA carry our brand?
Ask our sales team with your custom-label request — see Private Label.
Where is the lot number of a shipment?
On the packing list, carton by carton. Without it, send us the order reference.
How quickly do you answer document requests?
We reply within one business day. The desk answers every day, 10:00–22:00 China Standard Time (UTC+8).