The sample spectrum corresponds to that of the reference standard
No more than 3.0% difference of RS (on anhydrous basis )
C. Bromide test
Yellowish white precipitate formed
Specific rotation A
1.8% W/V in water; not more than 1.0% difference of RS at 325nm and 25°C (on anhydrous basis)
Specific rotation B
2.0% W/V in 0.1M HCl: +28°to +30°at 589nm and 20°C (on anhydrous basis)
Clarity of solution
5.0% W/V in alcohol:
5.2-6.5 (1 in 100 water solution )
Acidity or alkalinity
Not more than 0.4ml of 0.01MHCl consumed
Water (by KF Titratation )
a) For each of impurities A,B,C,D, not more than 0.5%
b) Among impurities A,B,C,D, not more than one greater than 0.25%
c) For each of unspecified impurities, not more than 0.10%
d) Total impurities not more than 1.0%
Impurities A,B,C,D: not detected
Residue on ignition
Not more than 0.1%
Not more htan 0.001%
No blue-green color develops
Assay A (by HPLC)
98.0%-102.0%(on anhydrous basis)
Assay B (by titration)
99.0%-101.0% (on anhydrous basis)
Methanol ≤ 3000ppm
Preserve in tight containers; protected from light
The product meets USP34 and EP7 monographs for Dextromethorphan Hydrobromide
Packaging & Shipping
1. We have our own GMP factory, cargo from our own factory are according to GMP strictly.
2. We also be as traders for API and chemicals
We have stable suppliers for most of these items. We will do many studies for our suppliers before we choose them as our suppliers, we will make credit investigations, and test quality from different batches, study some necessary quality certificate from them.
After approvement, we will make record in our suppliers’ system.
In case we develop new manufacturers as our supplier, we will do same work from the start.
3. We test the quality every time when we buy from suppliers by our own lab.
4. Preshipment samples can be supplied before shipment.
5. Samples of every batch we delivered can be kept for 2 years in our company.
We have stable shipping agent in Chinese main ports. With good service.
Photos will be taken for every shipment, including shipping marks, packages, and procedure of loading.
We use fast, direct vessels (If there is direct vessels), good shipping line, with good service. We signed long time agreement with these companies every year, with competitive freight.
For FCL, we supply 21 days free demurrage in destination, so consignee have enough time to clear the cargo in destination to avoid any unnecessary charge.
For LCL, we will confirm charges in destination before shipment with customers, to avoid any unreasonable, high charges for customers in destination from local shipping agent.
All docs. will be sent to customers for confirmation before shipment.
And all courier numbers, both for bank and for customer will be sent to customer for tracing.
Quality control and tech. service.
We can make different products in one container, combined shipment.
Good administration for both shipment and docs making.