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Since UPHW became the exclusive authorized distributor of medicinal-grade phosphates in Budenheim, Germany, and started to promote it in China, we have received feedback from many customers one after another.
After inquiring and researching the related patents of the original research agent, this article will start with the influence of phosphate on related substances, and try to provide a solution to this problem for customers' reference and verification
1.
The formula is composed of API, microcrystalline cellulose 102, anhydrous calcium hydrogen phosphate A60, sodium starch glycolate, and magnesium stearate.
2.
This part will cite the patent content of Pfizer amlodipine besylate maleate to illustrate
What is the result of its stability investigation? Come and see
test results:
| Data source: Patent-pharmaceutical composition containing amlodipine maleate
From this data, it can be seen that at the beginning of the investigation period, the 0-day related substance data of groups A and B using Budenheim anhydrous calcium hydrogen phosphate A60 were slightly higher than those of the other four groups.
It can be seen that, under the experimental conditions, whether it is a one-month or three-month investigation period, relatively speaking, the experimental groups (groups A and B) using Budenheim anhydrous calcium hydrogen phosphate A60 have the best control of related substances , API degradation (amlodipine aspartic acid) is also the least
3.
4.
Recommendation of other auxiliary materials of amlodipine
What is the pH situation of the three suppliers' anhydrous calcium hydrogen phosphate? See Table 2
Table 2.
| Data source: Patent-pharmaceutical composition containing amlodipine maleate
Comparing the pH value of calcium hydrogen phosphate shown in Table 2 with the results of the stability investigation in Table 1, it is not difficult to see the correlation of the pH value of calcium hydrogen phosphate on the influence of related substances in the stability investigation of amlodipine maleate product.
4.
Recommendation of other auxiliary materials of amlodipine
Microcrystalline cellulose 102: Dongchen Pharmaceutical TC102, particle size 85-125μm, bulk density 0.
28-0.
33g/cm³, good fluidity, CDE registration number F20180000805
.
TC102 electron micrograph and film (+0.
5% hard magnesium)
Shenzhen Youpuhui Pharmaceutical Co.
, Ltd.
Phone: 18126405453
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