Can domestic chromatography pure methanol acetonitrile replace imported ones among the top ten brands?

The fingerprint spectrum of medicinal materials should be replaced with domestically produced chromatography purity instead of imported ones. Don't switch batches for now. Select 3 brands and take 2-3 bottles of the same batch of methanol and acetonitrile each. Perform blank gradient, sample labeling, and system applicability, with a focus on recording the baseline drift at 210nm, the number of ghost peaks, and the retention time drift of the target peak. Domestic chromatographic purities such as Aladdin, McLean, Titan, and Kemio are all used in laboratories for HPLC, but batch differences can only be measured by oneself. A special price can be negotiated for packaging 40-60 bottles in 4L, which is usually much cheaper than imports. The quotation needs to be inquired from three suppliers based on the annual usage. The delivery time for spot goods is 3-5 days, while for non spot goods it is 1-2 weeks.

The chromatographic pure solvent focuses on UV absorption, evaporation residue, moisture, and gradient elution peaks. When purchasing, the supplier is required to provide a 210nm, 230nm UV scan or batch test report. Don't just look at the COA and write "pure chromatography". Acceptance can be done as a pure acetonitrile/methanol gradient blank. Integration to see if there is an unknown miscellaneous peak near 210nm. The threshold value is recommended to be set according to a certain proportion of the minimum peak area of your fingerprint. Some batch numbers of domestic acetonitrile will have one or two small peaks at low wavelengths, which will not necessarily affect quantification, but it is necessary to evaluate whether it falls near the peak of the medicinal material. For 40-60 bottle quantities, bulk supply of the same batch number can be requested to reduce the difference between batches.

You have such a large quantity, it is recommended to directly sign the annual framework with the brand or first level agent, instead of buying from retail channels. After opening a 4L bottle of solvent, moisture absorption and evaporation can affect the baseline and retention time. Upon arrival, check the aluminum foil seal and whether the batch number of the outer box is consistent. If there are different batch numbers in the same box, they should be rejected. Brand spot goods with warehouses in East China usually take 3-5 days, while bulk transfer usually takes 1-2 weeks. Price cannot be based solely on unit price. The cost of chromatographic impurity peak screening is high. It is recommended to include return terms and compensation for batch non conformities in the agreement. Domestic substitution is possible, but do not stop all imports at once and retain imports for key calibration purposes.

If the cost pressure is high, you can make a transition plan of "domestically produced, imported control": conventional fingerprint chromatography is pure with domestic chromatography, and the method confirmation or key batches are imported parallel control. Many batches of domestic chromatography of methanol and acetonitrile near 210 nm can meet the fingerprinting requirements of medicinal materials, but it is recommended to add online filters or protection columns to reduce solvent particles and ghost peak interference. The annual purchase of 40-60 bottles of 4L can be priced in stages, and domestic products are usually 30% -50% lower than imports. For specific inquiries, please contact us. The delivery period is generally 5-7 days for East China, and within 14 days for remote or tight lot numbers. Try two brands first, leaving samples in each batch.