ExcelMale
Menu
Home
What's new
Latest activity
Forums
New posts
Search forums
What's new
New posts
Latest activity
Videos
Lab Tests
Doctor Finder
Buy Books
About Us
Men’s Health Coaching
Log in
Register
What's new
Search
Search
Search titles only
By:
New posts
Search forums
Menu
Log in
Register
Navigation
Install the app
Install
More options
Contact us
Close Menu
Forums
Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Prions in hcg
JavaScript is disabled. For a better experience, please enable JavaScript in your browser before proceeding.
You are using an out of date browser. It may not display this or other websites correctly.
You should upgrade or use an
alternative browser
.
Reply to thread
Message
<blockquote data-quote="EmpowerPharmacy" data-source="post: 7178" data-attributes="member: 109"><p>We've been dispensing hCG for years and have never been asked this question or come across any papers or data about prions in hCG. Every prescription medication in the US has to be sourced from FDA Registered sources. That means that unless the FDA has visited a facility and approved it using its cGMP (current Good Manufacturing Practices) standards then it is not allowed to manufacture or distribute active ingredients that will ultimately be used in the US market.</p><p></p><p>HCG, being an FDA approved and monographed drug, has to meet certain standards to be accepted for use in the US. That means that the manufacturer of the hCG has to run tests on the chemical to verify it meets a high standard of quality in order for that chemical to be introduced into the US. For hCG these tests, which are shown on its Certificate of Analysis, include verification of solubility, endotoxin levels, potency, water content, transmissivity, estrogenic activity, HBV DNA, HCV RNA, and HIV RNA. Unless the chemical passes all of these specifications then it cannot be used in drug products destined for the US. Nowhere on hCG's monograph does it ask for testing of prions.</p><p></p><p>Nuclear is correct in that in order to be granted NDA (New Drug Application) through the FDA the manufacturing facility has to be FDA Registered and meet the standards required for that drug's monograph. Not only do the chemical's sources have to been of the highest grade, but the manufacturing process has to be as well. Currently, under USP (United States Pharmacopoeia) and EP (European Pharmacopoeia) standards testing for prions is not a requirement for hCG.</p></blockquote><p></p>
[QUOTE="EmpowerPharmacy, post: 7178, member: 109"] We've been dispensing hCG for years and have never been asked this question or come across any papers or data about prions in hCG. Every prescription medication in the US has to be sourced from FDA Registered sources. That means that unless the FDA has visited a facility and approved it using its cGMP (current Good Manufacturing Practices) standards then it is not allowed to manufacture or distribute active ingredients that will ultimately be used in the US market. HCG, being an FDA approved and monographed drug, has to meet certain standards to be accepted for use in the US. That means that the manufacturer of the hCG has to run tests on the chemical to verify it meets a high standard of quality in order for that chemical to be introduced into the US. For hCG these tests, which are shown on its Certificate of Analysis, include verification of solubility, endotoxin levels, potency, water content, transmissivity, estrogenic activity, HBV DNA, HCV RNA, and HIV RNA. Unless the chemical passes all of these specifications then it cannot be used in drug products destined for the US. Nowhere on hCG's monograph does it ask for testing of prions. Nuclear is correct in that in order to be granted NDA (New Drug Application) through the FDA the manufacturing facility has to be FDA Registered and meet the standards required for that drug's monograph. Not only do the chemical's sources have to been of the highest grade, but the manufacturing process has to be as well. Currently, under USP (United States Pharmacopoeia) and EP (European Pharmacopoeia) standards testing for prions is not a requirement for hCG. [/QUOTE]
Insert quotes…
Verification
Post reply
Share this page
Facebook
Twitter
Reddit
Pinterest
Tumblr
WhatsApp
Email
Share
Link
Sponsors
Forums
Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Prions in hcg
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to our use of cookies.
Accept
Learn more…
Top